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Philips North America FDA Recalls
127 recalls on file across devices, 3 of them Class I and 127 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 |
|---|
| Philips PIC iX Essentials REF:867093Class IIJul 31, 2026Due to software malfunction, patient information system may |
| Philips Patient Information Center iX REF:866389Class IIJul 31, 2026Due to software malfunction, patient information system may |
| Philips Achieva 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781196. 2. Model Number (REF): 781296.Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips SmartPath to Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 782118. 2. Model NumbeClass IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Upgrade to MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782130.Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Ingenia Elition S with MR Elastography (MRE). 1. Model Number (REF): 781357. 2. Model Number (REF): 7821Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF): 781356. 2. Model Number (REF): 782Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips SmartPath to dStream for XR and 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781270. 2. ModelClass IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF): 781359. 2. Model Number (REF): 782Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Evolution Upgrade 1.5T with MR Elastography (MRE). 1. Model Number (REF): 782116 2. Model Number (REF): 7Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Ingenia 3.0T CX with MR Elastography (MRE). 1. Model Number (REF): 781271. 2. Model Number (REF): 782105Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781260. 2. Model NumberClass IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Ingenia 1.5T CX with MR Elastography (MRE). 1. Model Number (REF): 781262.Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips MR 7700 with MR Elastography (MRE). 1. Model Number (REF): 782120. 2. Model Number (REF): 782153.Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Achieva 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781278.Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782143. 2. Model Number (REF):Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): 781358. 2. Model Number (REF): 7821Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model Number (REF): 782145.Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Ingenia 3.0T with MR Elastography (MRE). 1. Model Number (REF): 781342. 2. Model Number (REF): 781377. Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Achieva 1.5T Initial system with MR Elastography (MRE). 1. Model Number (REF): 781178.Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Philips Ingenia 1.5T with MR Elastography (MRE). 1. Model Number (REF): 781315. 2. Model Number (REF): 781341. Class IIApr 14, 2026The potential for stiffness value errors when a specific ran |
| Patient Information Center iX; Software Version Number: 4.5.0Class IIDec 22, 2025A recent software (SW) patch modifies Mobile Event Notificat |
| Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.Class IIDec 3, 2025The potential for stiffness value errors when viewing export |
| Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEMClass IIOct 27, 2025Between July 2024 and June 2025, Philips Azurion R3.0 system |
| Cardiac Workstation 5000; Model Number: 860439;Class IISep 12, 2025Failure of Environmental Stress Testing from a pinched power |
| Cardiac Workstation 7000; Model Number: 860441;Class IISep 12, 2025Failure of Environmental Stress Testing from a pinched power |
| SmartPath to Ingenia Elition X Model Numbers (REF): (1) 782118, (2) 782144;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Ingenia Elition S Model Numbers (REF): (1) 781357, (2) 782106, (3) 782137, (4) 782150 (China ONLY);Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Ingenia Elition X Model Numbers (REF): (1) 781358, (2) 782107, (3) 782119, (4) 782136, (5) 782151 (China ONLY);Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Upgrade to MR 7700 Model Number (REF): 782130;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| MR 7700 Model Numbers (REF): (1) 782120, (2) 782153;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Ingenia 1.5T S Model Number (REF): 781347;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Ingenia 1.5T Model Numbers (REF): (1) 781315, (2) 718641, (3) 781396, (4) 782101, (5) 782115, (6) 782140;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| SmartPath to dStream for XR and 3.0T Model Numbers (REF): (1) 781270, (2) 782113, (3) 782129;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| SmartPath to dStream for 3.0T Model Number (REF): 782145;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Achieva 3.0T; Model Numbers (REF): (1) 781177, (2) 781277, (3) 781278, (4) 781344, (5) 781345;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| MR 5300 Model Numbers (REF): (1) 782110, (2) 782135 (China ONLY), (3) 782152;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Ingenia 3.0T Model Numbers (REF): (1) 781342, (2) 781377, (3) 782103;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Achieva XR; Model Numbers (REF): (1) 781153, (2) 781253;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Ingenia Ambition S Model Numbers (REF): (1) 781359, (2) 782108, (3) 782133 (China ONLY), (4) 782139;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Ingenia Ambition X Model Numbers (REF): (1) 781356, (2) 782109, (3) 782138;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Intera 3.0T Quasar Dual Model Number (REF): 781150;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Ingenia 3.0T CX Model Numbers (REF): (1) 781271, (2) 782105;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Evolution Upgrade 3.0T Model Numbers (REF): (1) 782117, (2) 782143;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Evolution Upgrade 1.5T Model Numbers (REF): (1) 782116, (2) 782148;Class IIJun 30, 2025The potential for component failures in the Gradient Coil of |
| Intera 1.5T Achieva Nova Product Number: 781172;Class IIMay 29, 2025identified an issue where a component failure in the specifi |
| Intera 1.5T Explorer/Nova Dual Product Number: 781108;Class IIMay 29, 2025identified an issue where a component failure in the specifi |
| Intera 1.5T Achieva Nova-Dual Product Number: 781173;Class IIMay 29, 2025identified an issue where a component failure in the specifi |
| Intera Achieva 1.5T Pulsar; Product Number: 781171;Class IIMay 29, 2025identified an issue where a component failure in the specifi |
| Intera 1.5T Omni/Stellar; Product Number: 781104;Class IIMay 29, 2025identified an issue where a component failure in the specifi |
| SmartPath to dStream for 1.5T¿; Product Number: 782146;Class IIMay 29, 2025identified an issue where a component failure in the specifi |
| Intera 1.5T Achieva IT Nova Product Number: 781175Class IIMay 29, 2025identified an issue where a component failure in the specifi |
| Achieva XR Product Numbers: (1) 781153, (2) 781253;Class IIMay 29, 2025identified an issue where a component failure in the specifi |
| Intera 1.5T Master/Nova Product Number: 781106;Class IIMay 29, 2025identified an issue where a component failure in the specifi |
| IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 Class IIAug 30, 2024During a production process, Philips became aware of one Int |
| CareEvent Event Management System, Model Numbers 866435 and 866436 (CareEvent Upgrade), Software Version Number C.03.XClass IIFeb 28, 2024It was found that the Care Assist mobile application (versio |
| Patient Information Center iX (PIC iX), Model Numbers 866389, 866390 (PIC iX Expand), and 866424 (PIC iX Hardware) runniClass IIFeb 28, 2024It was found that the Care Assist mobile application (versio |
| Intera 1.5T Achieva Nova. Model (REF) Numbers 781172.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Achieva 1.5T. Model (REF) Numbers 781196, 781343, 781296.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Ingenia 1.5T CX. Model (REF) Numbers 781262, 781261.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera Achieva 1.5T Pulsar. Model (REF) Number 781171.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Achieva 1.5T Initial system. Model (REF) Numbers 781178.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Intera 1.5T Achieva Nova-Dual. Model (REF) Number 781173.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Achieva XR. Model (REF) Numbers 781153, 781253.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Ingenia 3.0T CX. Model (REF) Numbers 781271, 782105.Class IIJan 3, 2024The Quadrature Body Coil (QBC) seal adhesive may fail, creat |
| Achieva 1.5T, Model No. 781178, 781196, 781296Class IIIDec 29, 2023An incorrect electrical shock warning label may have been pl |
| SmartPath to dStream for 1.5T, Model No. 781260, 782112Class IIIDec 29, 2023An incorrect electrical shock warning label may have been pl |
| Achieva 3.0T, Model No. 781177Class IIIDec 29, 2023An incorrect electrical shock warning label may have been pl |
| Achieva 1.5T Conversion, Model No. 781283Class IIIDec 29, 2023An incorrect electrical shock warning label may have been pl |
| Intera 1.5T, Model No. 781195Class IIIDec 29, 2023An incorrect electrical shock warning label may have been pl |
| Ingenia Ambition X, Model No. 782109Class IIIDec 29, 2023An incorrect electrical shock warning label may have been pl |
| BrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format 453560279781 453560279791 4Class IDec 15, 2023Detector may unexpectedly fall due to a component failure. I |
| ProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref: (1)706100 (2)706110Class IIDec 15, 2023Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may |
| BrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit format 453560462131 45356074Class IDec 15, 2023Detector may unexpectedly fall due to a component failure. I |
| ProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F) system Ref:706150Class IIDec 15, 2023Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may |
| BrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit format 453560824741 4535608292Class IDec 15, 2023Detector may unexpectedly fall due to a component failure. I |
| Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871Class IIDec 7, 2023If the Patient Interface Monitor (PIM) Cable is plugged/unpl |
| BrightView, Gamma Camera System, Product Code 882480.Class IINov 30, 2023While using Pre-Programmed Motion during an extrinsic qualit |
| BrightView X, Gamma Camera, Product Code 882478Class IINov 30, 2023While using Pre-Programmed Motion during an extrinsic qualit |
| BrightView XCT, Gamma Camera, Product Code 882482Class IINov 30, 2023While using Pre-Programmed Motion during an extrinsic qualit |
| (1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX Expand, Model No. 866390 (3) PICClass IINov 28, 2023Push notifications may fail to send to the user under certai |
| (1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436Class IINov 28, 2023Push notifications may fail to send to the user under certai |
| Spectral CT on Rails, Software Version 5.1.0, Model Number 728334Class IIOct 9, 2023This recall is part of a 2-issue recall for the same system. |
| Spectral CT on Rails, Software Version 5.1.0, Model Number 728334Class IIOct 9, 2023When preparing for CCT Fluoroscopy mode and activating the C |
| Zenition 50 & 70 Mobile Surgery C-armClass IIOct 4, 2023Philips has become aware of an issue with the Philips Integr |
| BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems.Class IIOct 4, 2023Philips has become aware of an issue with the Philips Integr |
| Veradius Unity Mobile Surgery C-armClass IIOct 4, 2023Philips has become aware of an issue with the Philips Integr |
| Azurion IGTS Fixed SystemsClass IIOct 4, 2023Philips has become aware of an issue with the Philips Integr |
| Allura Xper IGTS Fixed SystemsClass IIOct 4, 2023Philips has become aware of an issue with the Philips Integr |
| Integris-Allura IGTS Fixed SystemsClass IIOct 4, 2023Philips has become aware of an issue with the Philips Integr |
| Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia ElitiClass IIJun 12, 2023During installation of the SmokeDetector Interlock, a connec |
| Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia ElitiClass IIJun 12, 2023The system operator is able to bypass the SmokeDetector Inte |
| MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)Class IIJun 12, 2023During installation of the SmokeDetector Interlock, a connec |
| MR 7700 Magnetic Resonance (MR) system, Product Numbers 782120 and 782130 (Upgrade to MR 7700)Class IIJun 12, 2023The system operator is able to bypass the SmokeDetector Inte |
| Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106Class IIJun 12, 2023The system operator is able to bypass the SmokeDetector Inte |
| Ingenia Elition S Magnetic Resonance (MR) system, Product Numbers 781357 and 782106Class IIJun 12, 2023During installation of the SmokeDetector Interlock, a connec |
| Incisive CT-Computed Tomography X-Ray System Model: 728143Class IIApr 25, 2023Metal mounting box on the rotating scanner on rotor (heat e |
| Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148Class IIApr 25, 2023Metal mounting box on the rotating scanner on rotor (heat e |
| Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146Class IIApr 25, 2023Metal mounting box on the rotating scanner on rotor (heat e |
| Incisive CT Plus-Computed Tomography X-Ray System Model: 728149Class IIApr 25, 2023Metal mounting box on the rotating scanner on rotor (heat e |
| Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, SoftwClass IIApr 19, 2023During extended operation of the MX40 with the PIC iX, the D |
| Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72814Class IIMar 20, 2023Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pres |
| Philips Incisive CT -Computed Tomography X-Ray System Model Number: 72813Class IIMar 20, 2023Multi-Function Foot Switch Unload Pedal Foot Entrapment-Pres |
| ProxiDiagnost N90 R.1.0Class IIMar 3, 2023Philips has identified a compliance issue where ProxiDiagnos |
| CombiDiagnost R90 R.1.0Class IIMar 3, 2023Philips has identified a compliance issue where ProxiDiagnos |
| CombiDiagnost R90 R1.1Class IIMar 3, 2023Philips has identified a compliance issue where ProxiDiagnos |
| IntelliVue G7m Anesthesia Gas Module, Product Number 866173Class IIJan 18, 2023The 866173 lntelliVue G7m Anesthesia Gas Modules could have |
| Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation systeClass IIJan 6, 2022Magnetic materials were used for the wheels of trolley. Whee |
| Ingenia Ambition X (Product Number 781356) - HA FlexTrak II (Accessory Number 989710008732), patient transportation systClass IIJan 6, 2022Magnetic materials were used for the wheels of trolley. Whee |
| Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation systemClass IIJan 6, 2022Magnetic materials were used for the wheels of trolley. Whee |
| (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)Class IIJul 15, 2021The sealed magnet will experience uncontrolled shutdown know |