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Philips North America Llc FDA Recalls
330 recalls on file across devices, 4 of them Class I and 292 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T), 3. 782103(3.0T), 4. 781271(3.0Class IIAug 21, 2026A software issue will terminate an examination during the im |
| Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T), 2. 781341(1.5T), 3. 781396(1.5TClass IIAug 21, 2026A software issue will terminate an examination during the im |
| Achieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers (REF): 1. 781196 (Achieva 1.5T), 2Class IIAug 21, 2026A software issue will terminate an examination during the im |
| Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;Class IIAug 21, 2026A software issue will terminate an examination during the im |
| Ingenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108 (S), 3. 782139 (S), 4. 781356 Class IIAug 21, 2026A software issue will terminate an examination during the im |
| Name (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T Achieva IT Nova (781175), 4. InterClass IIAug 21, 2026A software issue will terminate an examination during the im |
| Ingenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S), 3. 782137(S), 4. 781358(X), 5Class IIAug 21, 2026A software issue will terminate an examination during the im |
| MR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130 (Upgrade);Class IIAug 21, 2026A software issue will terminate an examination during the im |
| Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T), 2. 782148 (1.5T), 3. 782117 (Class IIAug 21, 2026A software issue will terminate an examination during the im |
| Achieva XR; Model Numbers (REF): 1. 781153, 2. 781253;Class IIAug 21, 2026A software issue will terminate an examination during the im |
| SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR and 3.0T, SmartPath to IngeniaClass IIAug 21, 2026A software issue will terminate an examination during the im |
| MR 5300 Model Number (REF): 1. 782110, 2. 782152;Class IIAug 21, 2026A software issue will terminate an examination during the im |
| Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232.Class IIAug 7, 2026Philips has identified an unintended radiation issue with th |
| Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product CoClass IIAug 7, 2026Philips has identified an unintended radiation issue with th |
| Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.xClass IIAug 7, 2026Philips has identified an unintended radiation issue with th |
| Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 ElitClass IIAug 7, 2026Philips has identified an unintended radiation issue with th |
| Cardiac Workstation 5000. Product Number: 860439.Class IIJul 1, 2026Device will intermittently provide inaccurate data related t |
| Cardiac Workstation 7000. Product Number: 860441.Class IIJul 1, 2026Device will intermittently provide inaccurate data related t |
| Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5Class IIJun 5, 2026Potential for device reset to default "NEW_DEVICE" state, wh |
| Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703AClass IIMay 26, 2026Monitor has incorrect assembly of the speaker connector whic |
| Philips Avalon Fetal Monitor, FM 30 Part numberM2703AClass IIMay 26, 2026Monitor has incorrect assembly of the speaker connector whic |
| DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035.Class IIMay 1, 2026System was delivered without the required Seismic kit for Wa |
| Spectral CT; Product Code (REF): 728333;Class IIJan 7, 2026As part of the CT systems sub assembly, thirty-two (32) fast |
| Spectral CT 7500 on Rails; Product Code (REF): 728334;Class IIJan 7, 2026As part of the CT systems sub assembly, thirty-two (32) fast |
| Brilliance iCT; Product Code (REF): 728306;Class IIJan 7, 2026As part of the CT systems sub assembly, thirty-two (32) fast |
| IQon Spectral CT; Product Code (REF): 728332;Class IIJan 7, 2026As part of the CT systems sub assembly, thirty-two (32) fast |
| Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.Class IIDec 12, 2025It was found that the MX40 device could not reconnect to the |
| IntelliVue Multi Measurement Server X2. Product Number: M3002A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX800. Product Number: 865240.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP70. Product Number: M8007A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP90. Product Number: M8010A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX850. Product Number: 866470.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX700. Product Number: 865241.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX500. Product Number: 866064.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP30. Product Number: M8002A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Multi-Measurement Module X3. Product Number: 867030.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX750. Product Number: 866471.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX550. Product Number: 866066.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP2. Product Number: M8102A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX400. Product Number: 866060.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX600. Product Number: 865242.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX450. Product Number: 866062.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP5. Product Number: M8105A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP50. Product Number: M8004A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue Patient Monitor MX100. Product Number: 867033.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP60. Product Number: M8005A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP40. Product Number: M8003A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP80. Product Number: M8008A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| IntelliVue MP20. Product Number: M8001A.Class IIOct 31, 2025Potential issue where the IntelliVue monitors did not alarm. |
| CT 5300; Software Version Number: 4.5, 5.0, 5.1;Class IIOct 29, 2025If the screws of tube heat exchanger on the rotating scanner |
| Incisive CT; Software Version Number: 4.5, 5.0, 5.1;Class IIOct 29, 2025If the screws of tube heat exchanger on the rotating scanner |
| Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 SlClass IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.Class IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.Class IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT Class IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.Class IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore OncoClass IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326Class IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.Class IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.Class IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.Class IIAug 13, 2025The patient support table (couch) may descend unexpectedly t |
| Spectral CT. Computed tomography X-ray system.Class IIMay 29, 2025Devices with affected software may experience two unintended |
| Product Name: SmartPath to dStream for 3.0T; Model Number: 782145Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Upgrade to MR 7700; Model Number: 782130;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Ingenia 1.5T; Model Numbers: (1) 781315, (2) 781341, (3) 781396, (4) 782101, (5) 782115, (6) 782140;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Ingenia 3.0T CX; Model Number: 781271;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: SmartPath to dStream for 1.5T; Model Numbers: (1) 781260, (2) 782112, (3) 782146Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Ingenia Elition S; Model Numbers: (1) 781357, (2) 782106, (3) 782137;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Ingenia Ambition S; Model Numbers: (1) 781359, (2) 782108, (3) 782139;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Evolution Upgrade 3.0T; Model Numbers: (1) 782117, (2) 782143;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: SmartPath to dStream for XR and 3.0T; Model Numbers: (1) 781270, (2) 782113;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: SmartPath to Ingenia Elition X; Model Numbers: (1) 782118, (2) 782144;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Ingenia Ambition X; Model Numbers: (1) 781356, (2) 782109, (3) 782138;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Ingenia 1.5T S; Model Number: 781347;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Evolution Upgrade 1.5T; Model Numbers: (1) 782116, (2) 782148;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Ingenia Elition X; Model Numbers: (1) 781358, (2) 782107, (3) 782136;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: MR 7700; Model Numbers: (1) 782120, (2) 782153;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Ingenia 1.5T CX; Model Number: 781262;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Product Name: Ingenia 3.0T; Model Numbers: (1) 781342, (2) 781377, (3) 782103;Class IIMay 13, 2025Potential for alignment errors in the cross reference line f |
| Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi IntubClass IIApr 7, 2025Disconnection of the adapter from the endotracheal tube can |
| Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.Class IIApr 1, 2025Unintended motion issues related to Interventional Control t |
| Philips DXR System, DuraDiagnost 4.1. Stationary X-Ray System.Class IIMar 10, 2025Potential for collimator to fall as a result of incorrect in |
| Philips DXR System, DuraDiagnost Rel. 4. Stationary X-Ray System.Class IIMar 10, 2025Potential for collimator to fall as a result of incorrect in |
| Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic,Class IIFeb 25, 2025A wireless foot switch pedal may get stuck in the active pos |
| Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, iClass IIFeb 25, 2025A wireless foot switch pedal may get stuck in the active pos |
| Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, inClass IIFeb 25, 2025A wireless foot switch pedal may get stuck in the active pos |
| IntelliVue Patient Monitor MX500. Model Number: 866064Class IIJan 15, 2025Potential failure to alarm for "No Device Data" INOP. The d |
| IntelliVue Patient Monitor MX400. Model Number: 866060Class IIJan 15, 2025Potential failure to alarm for "No Device Data" INOP. The d |
| IntelliVue Patient Monitor MX450. Model Number: 866062Class IIJan 15, 2025Potential failure to alarm for "No Device Data" INOP. The d |
| IntelliVue Patient Monitor MX550. Model Number: 866066Class IIJan 15, 2025Potential failure to alarm for "No Device Data" INOP. The d |
| IntelliBridge EC10 Module. Model Number: 865115Class IIJan 15, 2025Potential failure to alarm for "No Device Data" INOP. The d |
| Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216Class IINov 20, 2024The following four issues are included: 1. Certain Channel |
| Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.Class IINov 16, 2024Potential for a plan box not updated issue during Interventi |
| ST SENSE Breast Dx CoilClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| Mammotrak Interventional Coil 3.0TClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| Mammotrak Diagnostic Coil 3.0TClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| Mammotrak Interventional Coil 1.5TClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| dS Breast 7ch 3.0TClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| Mammotrak Diagnostic Coil 1.5TClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| SENSE Breast CoilClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| ST SENSE Breast CoilClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| SENSE Breast Coil 3.0T 7chClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| dS Breast 7ch 1.5TClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| dS Breast 16ch 1.5TClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| dS Breast 16ch 3.0TClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| Achieva TX Interventional Coil 3.0TClass IINov 4, 2024Potential safety issue where a patient may be harmed while p |
| Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra Class IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectrClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the inClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectrClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of thClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images anClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra oClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the inClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| Evolution Upgrade 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| Ingenia 3.0T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of tClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra Class IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic imClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images aClass IISep 3, 2024Integrated Radio Frequency (IRF) Carrier assembly screws may |
| IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866066. IndicateClass IIJun 28, 2024Philips lntelliVue Patient Monitors MX400/450/500/550 Shippe |
| IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. IndicateClass IIJun 28, 2024Philips lntelliVue Patient Monitors MX400/450/500/550 Shippe |
| IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866062. IndicatClass IIJun 28, 2024Philips lntelliVue Patient Monitors MX400/450/500/550 Shippe |
| IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. IndicateClass IIJun 28, 2024Philips lntelliVue Patient Monitors MX400/450/500/550 Shippe |
| SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and AchievClass IJun 5, 2024Potential for coils to heat up and harm patients (burn). |
| SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva SyClass IJun 5, 2024Potential for coils to heat up and harm patients (burn). |
| SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva SyClass IJun 5, 2024Potential for coils to heat up and harm patients (burn). |
| Avalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart and externally monitors fetal heClass IIMay 22, 2024Potential for inaccurate fetal heart rate measurements when |
| Ingenia Ambition S Model Number (REF): (1) 782139; (2) 782133; (3) 782108; (4) 781359Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Panorama HFO- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostiClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic deviClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, ProducClass IIMay 3, 2024Oil may leak from the HA FlexTrack Trolley onto the floor wh |
| HA FlexTrak II-Patient transport functionality to transport the patient from the preparation area to the MR system, ProClass IIMay 3, 2024Oil may leak from the HA FlexTrack Trolley onto the floor wh |
| SmartPath to dStream for 3.0T Model Number (REF): 782145Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device ModeClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnosticClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Marlin 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic devicClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diaClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostiClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a dClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. ModeClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device.Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| HA FlexTrak-Patient transport functionality to transport the patient from the preparation area to the MR system, ProducClass IIMay 3, 2024Oil may leak from the HA FlexTrack Trolley onto the floor wh |
| Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. MClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Achieva 3.0T for PET -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic dClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Achieva 3.0T TX for PET Model Number (REF): 781479Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Achieva 1.5T Initial system Model Number (REF): 781178Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| MR RT - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostiClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device MClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use aClass IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Ingenia 1.5T S Model Number (REF): 781347Class IIMay 3, 2024The g-MDU (global Mains Distribution Unit) L3 terminal conne |
| Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for Class IIApr 22, 2024Philips Ingenia Evolution systems with software R5.7.1 may n |
| Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated foClass IIApr 22, 2024Philips Ingenia Evolution systems with software R5.7.1 may n |
| Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.Class IIApr 19, 2024Event Catalog information does not save when copied and tran |
| Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728Class IIApr 15, 2024Metal mounting box on the rotating scanner on rotor (heat ch |
| Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728Class IIApr 15, 2024Metal mounting box on the rotating scanner on rotor (heat ch |
| The Oncology Essentials Package of the Spectral CT imaging system.Class IIMar 29, 2024Potential for third party oncology marking laser to be refle |
| Philips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC (Schneider Electric IT CorporatiClass IIMar 22, 2024Possible failure of Uninterruptable Power Supply (UPS) devic |
| GYROSCAN T5-NT, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.5T Omni/Stellar, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Achieva XR, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| SmartPath to dStream for XR and 3.0T, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.5T Master/Nova, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Ingenia 1.5T CX, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.5T Power/Pulsar, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| GYROSCAN ACS-NT, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Achieva 1.5T Initial, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera CV, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Evolution Upgrade 3.0T, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.5T Achieva Nova-Dual, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.0T Omni/Stellar, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| GYROSCAN T10-NT, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Ingenia 1.5T, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 3.0T Quasar Dual, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.5T Achieva IT Nova, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Achieva 1.5T Conversion, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Enterprise 1.5T, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| MR 5300, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Achieva 3.0TX for PET, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Achieva 1.5T, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Achieva 3.0T for PET, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.0T Power/Pulsar, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| MR 7700, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.5T, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| GYROSCAN T5, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera Achieva 1.5T Pulsar, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Ingenia 3.0T CX, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Ingenia 1.5T S, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Ingenia Elition S, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Ingenia Ambition X, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Ingenia Ambition S, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Ingenia 3.0T, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 0.5T Standard, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.5T Achieva Nova, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Ingenia Elition X, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| SmartPath to dStream for 1.5T, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.5T R11, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Achieva 3.0T, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| Intera 1.5T Explorer/Nova Dual, Magnetic Resonance System.Class IIMar 12, 2024Patient support table floor plate may be incorrectly install |
| DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGDClass IIFeb 15, 2024If the DIVA touch display generates touch inputs without use |
| Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.Class IINov 30, 2023Multiple software issues that affect device functionality. |
| Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systClass INov 17, 2023Firm was informed of an event in which the structural integr |
| Ingenia 1.5T CXClass IIOct 23, 2023Potential component failure in the Gradient Coil could produ |
| Achieva 1.5T ConversionClass IIOct 23, 2023Potential component failure in the Gradient Coil could produ |
| Achieva 1.5T Initial SystemClass IIOct 23, 2023Potential component failure in the Gradient Coil could produ |
| SmartPath to dStream for 1.5TClass IIOct 23, 2023Potential component failure in the Gradient Coil could produ |
| Intera 1.5T Power/PulsarClass IIOct 23, 2023Potential component failure in the Gradient Coil could produ |
| Intera 1.5TClass IIOct 23, 2023Potential component failure in the Gradient Coil could produ |
| Achieva 1.5TClass IIOct 23, 2023Potential component failure in the Gradient Coil could produ |
| Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiatiClass IIOct 9, 2023For oncology users: If the user performed off-set reconstruc |
| Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncoloClass IIOct 9, 2023For oncology users: If the user performed off-set reconstruc |
| Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed foClass IIOct 9, 2023For oncology users: If the user performed off-set reconstruc |
| EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.Class IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.Class IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) systemClass IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.Class IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.Class IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic imagesClass IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.Class IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.Class IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.Class IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| CombiDiagnost R90, Radiography and Fluoroscopy (R/F) systemClass IISep 21, 2023Potential for units suspended on the ceiling to fail and fal |
| EarlyVue VS30 Vital Signs Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) siClass IIAug 31, 2023A software issue prevents the monitor from alarming when the |
| EarlyVue VS30 Vitals Monitor, utilizing E01 (Oridion Microstream sidestream etCO2) and R21 (Masimo Rainbow RRa) simultanClass IIAug 31, 2023A software issue prevents the monitor from alarming when the |
| Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX PrClass IIAug 17, 2023Patient Information Center (PIC iX) Release 4.x Surveillanc |
| IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affecteClass IIJun 14, 2023Devices with Option CP2 and initially programmed to software |
| DigitalDiagnost C90, Model No. 712034 and 712035Class IIMay 19, 2023There is a software login in issue that may prevent the user |
| Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333Class IIMar 17, 2023Pressing the Unload Pedal of the foot switch to perform the |
| DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204Class IIMar 9, 2023If the PM for the telescopic carriage is not performed annua |
| Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201Class IIMar 9, 2023If the PM for the telescopic carriage is not performed annua |
| EARLYVUE VS30 VITAL SIGNS MONITOR Software Version A.00.02 and A.00.01 Product Number: 863359Class IIMar 6, 2023EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals m |
| EarlyVue VS30 Vitals monitor with Software Versions A.00.02 and A.00.01 Product Number: 863380Class IIMar 6, 2023EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals m |
| Philips Ingenia Elition S MR System, Model Numbers 781357, 782106, 782137Class IINov 22, 2022Gradient Coil may act as a heat source with a potential to p |
| Philips SmartPath to Ingenia Elition X MR System, Model Numbers 782118, 782132, 782144Class IINov 22, 2022Gradient Coil may act as a heat source with a potential to p |
| Philips Ingenia Elition X MR System, Model Numbers 781358, 782107, 782119, 782136Class IINov 22, 2022Gradient Coil may act as a heat source with a potential to p |
| Philips Upgrade to MR 7700 System, Model Number 782130Class IINov 22, 2022Gradient Coil may act as a heat source with a potential to p |
| Philips MR 7700 System, Model Number 782120Class IINov 22, 2022Gradient Coil may act as a heat source with a potential to p |
| Philips Fetal Spiral Electrode-intended for patients requiring fetal heart rate monitoring during labor. PN: 9898031376Class IINov 21, 2022Fetal Spiral Electrode (FSE) spiral tip of the FSE breaking |
| Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional general radioClass IIOct 21, 2022Potential table stop due to a broken tabletop cable: On the |
| MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.Class IISep 6, 2022Device may intermittently fail to produce audio. Turning the |
| The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into crossClass IIMar 29, 2022Three software issues affecting incorrect image display, err |
| DigitalDiagnost C50 1.1Class IIFeb 25, 2022Following a system restart where the Table Height 2 (TH2) is |
| Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization andClass IIFeb 22, 2022When a Neonatal patient is admitted, the Non-Invasive Blood |
| The IFU for the Autoclavable Temperature Probes: Part # 453564635891, providing in the packaging for the following produClass IIFeb 7, 2022Update to instructions for use regarding the cleaning and di |
| Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, Class IIFeb 4, 2022There is a potential for AED pads to experience gel separati |
| Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORSClass IIFeb 4, 2022There is a potential for AED pads to experience gel separati |
| Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model NumbersClass IIFeb 2, 2022Due to a software defect, the Philips StentBoost Live R2.0 m |
| eCareManager version 4.2.1, eCareManager version 4.3.2, eCareManager version 4.3.3, eCareManager version 4.5.1, eCareManClass IIJan 3, 2022eCareManager (eCM) Sentry Score software not approved for us |
| Heel Snuggler, Reference # 989805603411 99047Class IINov 29, 2021After the device was cleared by the FDA, Philips made change |
| Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010TClass IINov 29, 2021After the device was cleared by the FDA, Philips made change |
| Infant Heel Warmers w/strap, Reference # 989805603201 1223Class IINov 29, 2021After the device was cleared by the FDA, Philips made change |
| Medichoice Infant Heel Warmer, Reference # 989805643721 1079906Class IINov 29, 2021After the device was cleared by the FDA, Philips made change |
| Infa-Therm Transport Mattress, Reference Number 989805616831 1015Class IINov 26, 2021After the device was cleared by the FDA, Philips made change |
| Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chilClass IINov 24, 2021Due to a leak in the detector cooling system, cooling liquid |
| Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip trayClass IINov 24, 2021Due to a leak in the detector cooling system, cooling liquid |
| Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovasculClass IINov 19, 2021Set screws securing the two gliding rods of the Extra Monito |
| BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718Class IINov 12, 2021Instructions for Use do not specify the maximum surface temp |
| Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132Class IINov 12, 2021Instructions for Use do not specify the maximum surface temp |
| BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718Class IINov 12, 2021Instructions for Use do not specify the maximum surface temp |
| Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; AzurioClass IINov 12, 2021(1)Start-up problem: Intermittently at start-up of the syste |
| Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Class IIOct 29, 2021Wireless foot switch connection issues causing interruption |
| ProxiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 706100 and 706110Class IIOct 21, 2021If the system experiences an overvoltage / power surge it ca |
| CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031Class IIOct 21, 2021If the system experiences an overvoltage / power surge it ca |
| Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067, Class IISep 24, 2021When the user presses or releases both the APC (accept) butt |
| The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaClass IIAug 13, 2021Early life failure of the ADUs only occurs when the hospital |
| The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imClass IIAug 13, 2021Early life failure of the ADUs only occurs when the hospital |
| The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidancClass IIAug 13, 2021Early life failure of the ADUs only occurs when the hospital |
| Ingenia 3.0T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system canClass IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia Elition X-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system cClass IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia Elition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system cClass IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia Ambition S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system Class IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia Ambition X- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system cClass IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can prClass IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia 1.5T CX-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system canClass IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can Class IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can pClass IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia 1.5T Evolution-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The sysClass IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| SmartPath to dStream for XR and 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic dClass IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| SmartPath to dStream for 1.5T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. Class IIAug 11, 2021When using manual mode, the tabletop may not completely move |
| Ingenia 1.5T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can proClass IIJul 30, 2021Pressure relief valve 42 psi installed in the magnet assembl |
| Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system caClass IIJul 30, 2021Pressure relief valve 42 psi installed in the magnet assembl |
| Achieva 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can proClass IIJul 30, 2021Pressure relief valve 42 psi installed in the magnet assembl |
| Ingenia Elition S-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system caClass IIJul 30, 2021Pressure relief valve 42 psi installed in the magnet assembl |
| Ingenia 1.5T Evoluton- Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The systeClass IIJul 30, 2021Pressure relief valve 42 psi installed in the magnet assembl |
| Ingenia 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can proClass IIJul 30, 2021Pressure relief valve 42 psi installed in the magnet assembl |
| Ingenia CX 3.0T-Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can Class IIJul 30, 2021Pressure relief valve 42 psi installed in the magnet assembl |
| Philips, HEARTSTART, INFANT/CHILD - SMART PADS CARTRIDGE, REF: M5072A, (0-8 YEARS)< 55 lbs / 25 kg, CE 0123, NON-STERILEClass IIJul 16, 2021Infant/Child defibrillator pads contain incorrect labeling. |
| 728327 Ingenuity CT Upgrades-Computed Tomography X-ray systemClass IIJun 8, 2021When setting patient weight unit preferences to pounds, Sync |
| 728332 IQon Spectral CT-Computed Tomography X-ray systemClass IIJun 8, 2021When setting patient weight unit preferences to pounds, Sync |
| 728333 Spectral CT 7500 -Computed Tomography X-ray systemClass IIJun 8, 2021When setting patient weight unit preferences to pounds, Sync |
| Model 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed Tomography X-ray systemClass IIJun 8, 2021When setting patient weight unit preferences to pounds, Sync |
| 728306 Brilliance iCT-Computed Tomography X-ray systems 728305 Brilliance iCT UpgradesClass IIJun 8, 2021When setting patient weight unit preferences to pounds, Sync |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728333 - Spectral CT:Class IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 ConClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft may g |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882476 - Gemini TF Big Bore PET/CTClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon SpectClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and MX16 MoClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, IngenuiClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 ContinuClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft may g |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT sClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT sClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT sClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT sClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - BrilliaClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CTClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CTClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft goes |
| Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT Class IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft may g |
| Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 ContinuousClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft may g |
| Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CClass IIMay 1, 2021Significant wear of the Monitor Bracket Assembly shaft may g |
| Ingenia Ambition X - Model Number: 781356, Diagnostic MR system. ***Updated November 2023*** Added Model Number 782109 Class IIApr 23, 2021The MR magnet is equipped with 4 lifting blocks, which are p |
| Ingenia Ambition S - Model Number: 781359 Diagnostic MR system.Class IIApr 23, 2021The MR magnet is equipped with 4 lifting blocks, which are p |
| BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Class IIApr 13, 2021Cooling Unit (CLU) expelled out of a CT gantry of an iCT sys |
| Philips Xper Flex Cardio (FC2010, Procedure Room and FC2020, Bedside Monitor) devices - intended for use by professionalClass IIMar 29, 2021Performance issues with the Xper Flex Cardio Physio Monitori |
| Philips SureSigns VM4, VM6 and VM8 - Product Usage: patient monitors-for monitoring, recording and alarming of multiple Class IIMar 23, 2021Fail to Comply with Chinese Standard YY1079-2008: Clauses 4. |
| Incisive CT Computed Tomography X-ray System Model: 728143Class IIFeb 22, 2021Actuators in the Incisive gantry could result in the gantry |
| Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304Class IIFeb 9, 2021Customers were not notified of previous recalls associated w |
| Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068AClass IIFeb 9, 2021Customers were not notified of previous recalls associated w |
| Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861AClass IIFeb 9, 2021Customers were not notified of previous recalls associated w |
| Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067AClass IIFeb 9, 2021Customers were not notified of previous recalls associated w |
| IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage:Class IIFeb 2, 2021Manufacturing failed to follow process steps resulting in th |