Browse Device Recalls
702 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 702 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 702 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 24, 2022 | Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Int... | It may occur that after system startup no stand movement is possible any longer in the event of a... | Class II | Siemens Medical Solutions USA, Inc |
| May 20, 2022 | Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 | During system tests, an increased wearing of the Image acquisition system fans has been observed.... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 13, 2022 | Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 ... | Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis L... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 11, 2022 | Artis icono floor-angiography systems developed for single and biplane diagno... | if the protective earth is interrupted and an additional fault leads to a fault current, the dete... | Class II | Siemens Medical Solutions USA, Inc |
| Apr 11, 2022 | Artis icono biplane -angiography systems developed for single and biplane dia... | if the protective earth is interrupted and an additional fault leads to a fault current, the dete... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 11, 2022 | Symbia Intevo Bold and Symbia Intevo 6 SPECT/CT Systems | There is a quality issue with the three bolts that hold the CT balancing weights, which could cre... | Class II | Siemens Medical Solutions USA, Inc. |
| Mar 7, 2022 | YSIO X.Pree | For the automated multi-image-acquisition procedure Ortho x-ray collimation is set in a preparati... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Mod... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Nu... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on syngo.via Model Number ... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Num... | Upgraded software version makes an automatic change in laser configuration settings for "markerle... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now ... | Software error may result in sporadic problems causing scanning workflow interruptions, unexpecte... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 7, 2022 | Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , | Transducers (component of ultrasound system) may exceed recommended thermal index limits | Class II | Siemens Medical Solutions USA, Inc. |
| Feb 25, 2022 | syngo Application software VE20 (Material Number 10848815) installed on the ... | After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and ve... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUE... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Artis icono biplane- in combination with a Siemens Healthineers table or Tru... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 25, 2022 | Artis icono floor in combination with a Siemens Healthineers table or Trumpf... | Five potential software issues affecting Artis pheno and Artis icono systems in combination with ... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zeego, Model Number 10280959 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee floor, Model Number 10094135 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q.zen ceiling, Model Number 10848354 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q biplane, Model Number 10848282 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q.zen biplane, Model Number 10848355 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee ceiling, Model Number 10094137 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q floor, Model Number 10848280 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee biplane MN, Model Number 10094143 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee multi-purpose, Model Number 10094139 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee biplane, Model Number 10094141 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q.zen floor, Model Number 10848353 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q zeego, Model Number 10848283 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis Q ceiling, Model Number 10848281 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Feb 23, 2022 | Artis zee floor MN, Model Number 10094142 | If the coolant level in the cooling circuit drops below a certain level, this may result in a sit... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 31, 2022 | Ysiosystem with VC10 software version, Model Number 10281013. Radiographic s... | Siemens Healthineers has identified a software error in previous software version VB10 for the Ys... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 19, 2022 | Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model:... | The clip store function in the ultrasound imaging system does not work when the system has a disk... | Class II | Siemens Medical Solutions USA, Inc. |
| Dec 9, 2021 | ARTISTE with syngo RT Therapist-linear accelerator systems to deliver X-Ray p... | Potential safety issue under specific preconditons that may result in a user selecting the wrong ... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 23, 2021 | 1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, mat... | Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Confidence -Computed tomography systems Model 10590100 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Definition Edge -Computed tomography system Model 10590000 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Definition AS-Computed tomography system Model 8098027 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 19, 2021 | SOMATOM Edge Plus-Computed tomography system Model 1026700 | Software version VB20_SP5 my lead to a relevant degradation of head image quality, a potential ri... | Class II | Siemens Medical Solutions USA, Inc |
| Nov 12, 2021 | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B | Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace... | Class II | Siemens Medical Solutions USA, Inc. |
| Oct 20, 2021 | Artis zee multi-purpose with software VD12-angiography systems developed for ... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q.zen floor with software VD12-angiography systems developed for single... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q ceiling with software VD12-angiography systems developed for single a... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis zee biplane with software VD12-angiography systems developed for single... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q.zen biplane with software VD12- angiography systems developed for sin... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis zee ceiling with software VD12-angiography systems developed for single... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis zee floor with software VD12-angiography systems developed for single a... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q biplane with software VD12-angiography systems developed for single a... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q floor with software VD12- angiography systems developed for single an... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
| Oct 20, 2021 | Artis Q.zen ceiling with software VD12-angiography systems developed for sing... | If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultan... | Class II | Siemens Medical Solutions USA, Inc |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.