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Siemens Medical Solutions USA, Inc FDA Recalls
187 recalls on file across devices, 16 of them Class I and 149 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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| ARTIS icono ceiling. Model Number: 11328100.Class IIJun 8, 2026Potential issue with the Display ceiling suspension (DCS Fix |
| ARTIS icono floor. Model Number: 11327700.Class IIMay 20, 2026Potential for loss of movement capability after adjusting th |
| ARTIS icono biplane. Model Number: 11327600.Class IIMay 20, 2026Potential for loss of movement capability after adjusting th |
| ARTIS icono ceiling. Model Number: 11328100.Class IIMay 20, 2026Potential for loss of movement capability after adjusting th |
| ARTIS Pheno VE30A and VE40A, Model 10849000Class IIMar 12, 2026During 3D acquisitions, lighter and darker patient images ma |
| ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.Class IIMar 10, 2026During patient examinations, the system may sporadically dis |
| ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS iClass IIMar 9, 2026During patient examinations, the system may sporadically dis |
| ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray systemClass IIMar 9, 2026During patient examinations, the system may sporadically dis |
| Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software VeClass IIDec 29, 2025Ortho images acquired with preset automatic horizontal flip |
| Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software VeClass IIDec 29, 2025Ortho images acquired with preset automatic horizontal flip |
| SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTSClass IIDec 19, 2025To remove the software applications from certain CT systems |
| NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPEClass IIDec 19, 2025To remove the software applications from certain CT systems |
| NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASClass IIDec 19, 2025To remove the software applications from certain CT systems |
| NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTSClass IIDec 19, 2025To remove the software applications from certain CT systems |
| LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471Class IIDec 5, 2025A potential issue associated with LUMINOS Lotus Max and Lumi |
| MAMMOMAT Inspiration;Class IIOct 24, 2025There were instances where the operator table was sold toget |
| MAMMOMAT Fusion;Class IIOct 24, 2025There were instances where the operator table was sold toget |
| MAMMOMAT Revelation;Class IIOct 24, 2025There were instances where the operator table was sold toget |
| MAGNETOM Cima.X Upgrade. Model Number: 11689304.Class IOct 1, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2. MAGNETOM Spectra (CN). Model NumbeClass IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Cima.X (DE). Model Number: 11647158.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Prisma. Model Number: 10849582.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Vida Fit. Model Number: 11410481.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Verio Dot Upgrade. Model Number: 10684334.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Skyra fit. Model Number: 10849580.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Connectom.X. Model Number: 11371480.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| Biograph mMR. Model Number: 10433372.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433, K183254, K192924, K203443, K213693,Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K1Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Verio. Model Number: 10276755.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Lumina (DE). Model Number: 11344916.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| MAGNETOM Verio Dot. Model Number: 10684333.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| BIOGRAPH One (DE). Model Number: 11689172.Class IAug 28, 2025There is a potential for an ice blockage to form or currentl |
| Artis Pheno. Image-Intensified Flouroscopic X-Ray System.Class IIAug 12, 2025Limited system movements after startup . |
| UROSKOP Omnia Max. Model Number: 10762473Class IIJun 4, 2025A resistor in the frequency inverter may strongly overheat p |
| UROSKOP Omnia. Model Number: 10094910Class IIJun 4, 2025A resistor in the frequency inverter may strongly overheat p |
| interventional fluoroscopic x-ray systemClass IIMay 15, 2025In very rare situations, communication between the sensor me |
| interventional fluoroscopic x-ray systemClass IIMay 15, 2025In very rare situations, communication between the sensor me |
| interventional fluoroscopic x-ray systemClass IIMay 15, 2025In very rare situations, communication between the sensor me |
| ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventionClass IIMay 15, 2025In very rare situations, communication between the sensor me |
| ARTIS One Angiographic X-Ray SystemClass IIJan 2, 2025A potential issue with ARTIS One systems was identified. In |
| ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic UltrasoClass IIAug 15, 2024If ultrasound systems with software, are changed from factor |
| ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with softwareClass IIAug 15, 2024If ultrasound systems with software, are changed from factor |
| ACUSON Juniper 1.0, 1.5, 2.0, 2.5 Diagnostic Ultrasound Systems, REF: 11335791, with software. ACUSON Juniper Select 2.Class IIAug 15, 2024If ultrasound systems with software, are changed from factor |
| Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be uClass IIJul 3, 2024If the Sensis documentation functionality is used during add |
| Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diaClass IIJul 3, 2024If the Sensis documentation functionality is used during add |
| Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hClass IIJul 3, 2024If the Sensis documentation functionality is used during add |
| Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post Processing Workstation-Intended Class IIJul 3, 2024If the Sensis documentation functionality is used during add |
| LUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image ModeClass IIJul 2, 2024The support arm may unintentionally lower resulting in injur |
| Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image Model NumClass IIJul 2, 2024The support arm may unintentionally lower resulting in injur |
| Luminos dRF Max- Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. ModelClass IIJul 2, 2024The support arm may unintentionally lower resulting in injur |
| Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. ModClass IIJul 2, 2024The support arm may unintentionally lower resulting in injur |
| AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO Class IIMay 31, 2024Short circuit in the power supply unit (PSU) of the Touch Di |
| AXIOM Vertix MD - The Vertix MD Trauma has been specially designed for examining emergency and accident patients as welClass IIMay 31, 2024Short circuit in the power supply unit (PSU) of the Touch Di |
| AXIOM MULTIX MP - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO Class IIMay 31, 2024Short circuit in the power supply unit (PSU) of the Touch Di |
| MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with theClass IIMay 31, 2024Short circuit in the power supply unit (PSU) of the Touch Di |
| AXIOM MULTIX MP - Inended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO aClass IIMay 31, 2024Short circuit in the power supply unit (PSU) of the Touch Di |
| ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is a component and has been specially designed for examining emergeClass IIMay 31, 2024Short circuit in the power supply unit (PSU) of the Touch Di |
| AXIOM Vertix Solitaire - The Vertix MD Trauma has been specially designed for examining emergency and accident patientsClass IIMay 31, 2024Short circuit in the power supply unit (PSU) of the Touch Di |
| AXIOM MULTIX MT - Intended Radiographic X ray Table is a patient table used in conjunction with the Siemens Multix PRO aClass IIMay 31, 2024Short circuit in the power supply unit (PSU) of the Touch Di |
| MULTIX TOP - Intended Use: The Multix TOP I PRO Radiographic X ray Table is a patient table used in conjunction with theClass IIMay 31, 2024Short circuit in the power supply unit (PSU) of the Touch Di |
| Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor- 10094135 Artis zee ceiling- 1Class IIMar 21, 2024Coolant level in the cooling circuit drops below a certain l |
| ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10GClass IIFeb 23, 2024On ultrasound systems, when Cardiac DICOM SR feature is conf |
| ACUSON Maple Diagnostic Ultrasound System, REF: 11711750, ACUSON Maple Select, REF: 11711779, running software version VClass IIFeb 23, 2024On ultrasound systems, when Cardiac DICOM SR feature is conf |
| ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF:Class IIFeb 23, 2024On ultrasound systems, when Cardiac DICOM SR feature is conf |
| Sensis Vibe HemoClass IINov 29, 2023The possibility of the Sensis documentation functionality ap |
| ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100Class IIOct 17, 2023Potential hardware issue for ARTIS icono ceiling system: col |
| Mobilett Mira wireless (VA20) mobile x-ray system(s)Class IIOct 5, 2023Due to the incorrect mounting of the buzzer component, there |
| ***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System. Designed for the surgical environmentClass IISep 12, 2023Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 |
| Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment. 11105200Class IISep 12, 2023Software issue for Cios Alpha, Cios Flow, and Cios Spin VA30 |
| (1) Over-ear headphones used with the MAGNETOM Amira MAGNETOM Free.Star MAGNETOM Sempra, MAGNETOM Free.Max, MAGNETOM MicClass IISep 1, 2023In some cases, when lubricating grease is present within th |
| ACUSON Redwood 2.0 ultrasound systems, REF: 11503314Class IIJul 13, 2023If a user-generated preset for an 18L6 transducer created on |
| The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical SensClass IIJul 12, 2023During a whole-body planar scan with auto-contour, there is |
| ARTIS icono floor-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures.Class IIJun 19, 2023Due to a hardware issue in the cable connectors of the syste |
| ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. MateClass IIJun 19, 2023Due to a hardware issue in the cable connectors of the syste |
| ARTIS icono biplane -Angiography systems developed for single and biplane diagnostic imaging and interventional procedurClass IIJun 19, 2023Due to a hardware issue in the cable connectors of the syste |
| Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Class IIJun 5, 2023Incorrect glue was applied on the plexiglass sheet on the si |
| ARTIS one with a hybrid cable- An angiography system developed for diagnostic imaging and interventional procedures. MaClass IIMar 21, 2023Examination room monitor connected with the hybrid cable may |
| ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems developed for sClass IIFeb 2, 2023If, during the procedure, X-ray has been released and a refe |
| ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material #Class IIFeb 2, 2023In the event of any unintended table movement, the system ma |
| SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4RClass IIJan 16, 2023This is a potential problem with the locking mechanism that |
| SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, EmissionClass IIJan 16, 2023This is a potential problem with the locking mechanism that |
| SIEMENS Biograph Vision: a) 450, b) 600, c) 600 EdgeClass IIJan 16, 2023This is a potential problem with the locking mechanism that |
| Software : myNeedle Guide 2D license, myNeedle Guide 2D AWP only Workflow license, or myNeedle Guide 3D license. UseClass IIDec 22, 2022In the syngo.CT VA40 and syngo.CT VA50 myNeedle Guide applic |
| Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studie ModeClass IIDec 21, 2022Potential risk of collision with the ceiling, wall, or objec |
| Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic studie MClass IIDec 21, 2022Potential risk of collision with the ceiling, wall, or objec |
| Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies. Model NumberClass IIDec 21, 2022Potential risk of collision with the ceiling, wall, or objec |
| Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies ModClass IIDec 21, 2022Potential risk of collision with the ceiling, wall, or objec |
| Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10Class IIDec 21, 2022Potential risk of collision with the ceiling, wall, or objec |
| ARTIS pheno, ARTIS icono biplane, and ARTIS icono floorClass IIDec 16, 2022Mechanical connection between the tabletop and table base ma |
| System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee bClass IIDec 16, 2022In rare cases, the system may only boot into backup mode aft |
| AXIOM Luminos AgileClass IIDec 9, 2022There is potential for the footrest to detach from the patie |
| AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRFClass IIDec 9, 2022There is potential for the footrest to detach from the patie |
| Luminos Agile Max, Luminos dRF Max, and LUMINOS Lotus MaxClass IIDec 9, 2022There is potential for the footrest to detach from the patie |
| LUMINOS Lotus Max (VF11)Class IINov 23, 2022Under certain unlikely circumstances during a fluoroscopic e |
| Luminos Agile Max (VE10, VF10, VF11)Class IINov 23, 2022Under certain unlikely circumstances during a fluoroscopic e |
| Luminos dRF Max (VE10, VF10, VF11)Class IINov 23, 2022Under certain unlikely circumstances during a fluoroscopic e |
| Programmable Diagnostic ComputerClass IINov 16, 2022The firm will be performing a software update to address a s |
| ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 IntendClass IINov 9, 2022When selecting the site fraction group for treatment, the Us |
| ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000Class IISep 20, 2022Siemens has become aware of three potential software issues |
| Artis pheno- Model No. 10849000Class IIAug 10, 2022Siemens has become aware of a potential hardware issue with |
| Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeeClass IIAug 10, 2022Siemens has become aware of a potential hardware issue with |
| Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700Class IIAug 10, 2022Siemens has become aware of a potential hardware issue with |
| AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, CoClass IIIJul 12, 2022The Sensis Signal Input Box provides hooks as a milled item |
| Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizatClass IIJun 15, 2022Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter |
| Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/oClass IIJun 15, 2022Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter |
| Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000Class IIJun 10, 2022A video signal from one of the transceivers of the Large Dis |
| Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray SystemClass IIMay 24, 2022It may occur that after system startup no stand movement is |
| Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600Class IIMay 20, 2022During system tests, an increased wearing of the Image acqui |
| Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 Class IIApr 13, 2022Siemens has become aware of three potential software issues |
| Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedurClass IIApr 11, 2022if the protective earth is interrupted and an additional fau |
| Artis icono floor-angiography systems developed for single and biplane diagnostic imaging and interventional procedures Class IIApr 11, 2022if the protective earth is interrupted and an additional fau |
| Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT SystemsClass IIMar 11, 2022There is a quality issue with the three bolts that hold the |
| YSIO X.PreeClass IIMar 7, 2022For the automated multi-image-acquisition procedure Ortho x- |
| syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngClass IIMar 7, 2022Upgraded software version makes an automatic change in laser |
| syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number 10496180. Running on servers with syngo.viaClass IIMar 7, 2022Upgraded software version makes an automatic change in laser |
| SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 110616Class IIMar 7, 2022Software error may result in sporadic problems causing scann |
| syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngClass IIMar 7, 2022Upgraded software version makes an automatic change in laser |
| Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,Class IIMar 7, 2022Transducers (component of ultrasound system) may exceed reco |
| syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers witClass IIMar 7, 2022Upgraded software version makes an automatic change in laser |
| Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use singleClass IIFeb 25, 2022Five potential software issues affecting Artis pheno and Art |
| Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplClass IIFeb 25, 2022Five potential software issues affecting Artis pheno and Art |
| Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single anClass IIFeb 25, 2022Five potential software issues affecting Artis pheno and Art |
| syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follClass IIFeb 25, 2022After CT image data from Toshiba is loaded, image mirroring |
| Artis Q zeego, Model Number 10848283Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis Q.zen biplane, Model Number 10848355Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis zeego, Model Number 10280959Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis zee multi-purpose, Model Number 10094139Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis zee biplane, Model Number 10094141Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis zee biplane MN, Model Number 10094143Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis zee ceiling, Model Number 10094137Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis Q ceiling, Model Number 10848281Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis Q.zen floor, Model Number 10848353Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis zee floor, Model Number 10094135Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis Q floor, Model Number 10848280Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis zee floor MN, Model Number 10094142Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis Q.zen ceiling, Model Number 10848354Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Artis Q biplane, Model Number 10848282Class IIFeb 23, 2022If the coolant level in the cooling circuit drops below a ce |
| Ysiosystem with VC10 software version, Model Number 10281013. Radiographic systemClass IIJan 31, 2022Siemens Healthineers has identified a software error in prev |
| Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging sClass IIJan 19, 2022The clip store function in the ultrasound imaging system doe |
| ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray photon and electron radiation for the therapClass IIDec 9, 2021Potential safety issue under specific preconditons that may |
| 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. SClass IINov 23, 2021Software error which affects Sensis Vibe Hemo, Sensis and Se |
| SOMATOM Confidence -Computed tomography systems Model 10590100Class IINov 19, 2021Software version VB20_SP5 my lead to a relevant degradation |
| SOMATOM Definition Edge -Computed tomography system Model 10590000Class IINov 19, 2021Software version VB20_SP5 my lead to a relevant degradation |
| SOMATOM Definition AS-Computed tomography system Model 8098027Class IINov 19, 2021Software version VB20_SP5 my lead to a relevant degradation |
| SOMATOM Edge Plus-Computed tomography system Model 1026700Class IINov 19, 2021Software version VB20_SP5 my lead to a relevant degradation |
| ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/BClass IINov 12, 2021Due to a calculation error in the measurement when using 2D |
| Artis Q.zen biplane with software VD12- angiography systems developed for single and biplane diagnostic imaging and inteClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interveClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis Q.zen floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interveClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventiClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and iClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis zee biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interveClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventClass IIOct 20, 2021If SID (source-to-image distance) lift movement is activated |
| Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000Class IIOct 12, 2021Four potential software issues with Artis pheno and Artis ic |
| Artis icono biplane with software VE20C-diagnostic imaging angiography system Model: 11327600Class IIOct 12, 2021Four potential software issues with Artis pheno and Artis ic |
| Artis icono floor with software VE20C-diagnostic imaging angiography system Model: 11327700Class IIOct 12, 2021Four potential software issues with Artis pheno and Artis ic |
| Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641Class IIOct 5, 2021System operator manual states that the system should be rebo |
| Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 in combination with the following workplace/Class IISep 24, 2021Software error, the software can produce an incorrect interp |
| SOMATOM Force with software syngo.CT VB20 Model #10742326Class IIAug 30, 2021software syngo.CT VB20 in the installed base, with or withou |
| SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000Class IIAug 30, 2021software syngo.CT VB20 in the installed base, with or withou |
| SOMATOM Definition AS with software syngo.CT VB20 Model #8098027Class IIAug 30, 2021software syngo.CT VB20 in the installed base, with or withou |
| SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000Class IIAug 30, 2021software syngo.CT VB20 in the installed base, with or withou |
| SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603Class IIAug 30, 2021software syngo.CT VB20 in the installed base, with or withou |
| SOMATOM Confidence with software syngo.CT VB20 Model #10590100Class IIAug 30, 2021software syngo.CT VB20 in the installed base, with or withou |
| SOMATOM Drive with software syngo.CT VB20 Model #10431700Class IIAug 30, 2021software syngo.CT VB20 in the installed base, with or withou |
| Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP5, VA30A_SP2, VA30A_SP2a, VA30A_SP3,VA30A_FClass IIAug 18, 2021Software versions may result in sporadic problems causing sc |
| MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A with license SW-Key CT_RT_IMA_SUITE_SYNTHEClass IIAug 16, 2021Potential for data loss when using the contouring or patient |
| syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SOMATOM go.Now SOMATOM go.Up SOMATOM go.AClass IIAug 16, 2021Potential for data loss when using the contouring or patient |
| syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended for Radiation Therapy Treatment Material Class IIAug 16, 2021Potential for data loss when using the contouring or patient |
| ACUSON Juniper Diagnostic Ultrasound SystemClass IIJul 12, 2021Due to intermittent failures of the power supply in the ultr |
| Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 1009Class IIJun 30, 2021Due to a software error, the IAS (Image Acquisition System) |
| ARTIS pheno- angiography systems developed for single and biplane diagnostic imaging and interventional procedures. ModClass IIMay 27, 2021Software error VE10B -In case of a fault within the drivetra |
| Multitom RAX with software version VF10Class IIApr 20, 2021Siemens identified two issues, In some cases, it is possible |
| Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventiClass IIMar 30, 2021Due to inappropriate cleaning, some Artis systems show unexp |
| Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 10094137Class IIMar 26, 2021Some Artis zee ceiling systems show an increased abrasion of |
| Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849Class IIMar 19, 2021Siemens has become aware of a potential issue with software |
| Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body inClass IIMar 10, 2021A patient image was assigned to a different patient during i |
| Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-ProcessinClass IIMar 4, 2021Due to the configuration of certain Windows Service Permiss |
| Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM goClass IIMar 3, 2021SOMATOM systems-issues in with software syngo.CT VA30A_SP2 o |
| Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and intervClass IIFeb 26, 2021Siemens has become aware of a potential issue in which the i |
| Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual staClass IIFeb 4, 2021The ultrasound system averages the Mean Sac Diameter (MSD) a |
| Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administratiClass IIJan 27, 2021System may sporadically freeze (lock-up) during operation or |