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.

Clear
DateProductReasonClassFirm
Oct 12, 2021 Artis icono floor with software VE20C-diagnostic imaging angiography system ... Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... Class II Siemens Medical Solutions USA, Inc
Oct 12, 2021 Artis icono biplane with software VE20C-diagnostic imaging angiography system... Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... Class II Siemens Medical Solutions USA, Inc
Oct 12, 2021 Artis pheno with software VE20C- diagnostic imaging angiography system Mode... Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. U... Class II Siemens Medical Solutions USA, Inc
Oct 5, 2021 Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10... System operator manual states that the system should be rebooted once, every 7 days. In some case... Class II Siemens Medical Solutions USA, Inc
Sep 24, 2021 Artis zeego, Fluoroscopic X-Ray System Models: 10280959,10502505, 10848283 i... Software error, the software can produce an incorrect interpretation of the table rotation if the... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Drive with software syngo.CT VB20 Model #10431700 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Confidence with software syngo.CT VB20 Model #10590100 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Force with software syngo.CT VB20 Model #10742326 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Definition AS with software syngo.CT VB20 Model #8098027 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 30, 2021 SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000 software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1... Class II Siemens Medical Solutions USA, Inc
Aug 18, 2021 Computed tomography x-ray systems with software syngo.CT VA20A_SP4a, VA20A_SP... Software versions may result in sporadic problems causing scanning workflow interruptions and un... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A, VA30A and VA31A... Potential for data loss when using the contouring or patient marking workflow when editing a stru... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 syngo.via RT Image Suite with syngo.via VB30, VB40, VB50 and VB60- Intended... Potential for data loss when using the contouring or patient marking workflow when editing a stru... Class II Siemens Medical Solutions USA, Inc
Aug 16, 2021 syngo.CT VA20A, VA30A and VA40A in: syngo.via RT Image Suite / Sim&Go SO... Potential for data loss when using the contouring or patient marking workflow when editing a stru... Class II Siemens Medical Solutions USA, Inc
Jul 12, 2021 ACUSON Juniper Diagnostic Ultrasound System Due to intermittent failures of the power supply in the ultrasound system which renders it inoper... Class II Siemens Medical Solutions USA, Inc.
Jun 30, 2021 Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Ar... Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/... Class II Siemens Medical Solutions USA, Inc
May 27, 2021 ARTIS pheno- angiography systems developed for single and biplane diagnostic ... Software error VE10B -In case of a fault within the drivetrain of an axis and while performing a ... Class II Siemens Medical Solutions USA, Inc
Apr 20, 2021 Multitom RAX with software version VF10 Siemens identified two issues, In some cases, it is possible to perform an image acquisition alth... Class II Siemens Medical Solutions USA, Inc
Mar 30, 2021 Artis systems - Product Usage: an angiography systems developed for single an... Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts whic... Class II Siemens Medical Solutions USA, Inc
Mar 26, 2021 Artis zee ceiling-interventional Fluoroscopic X-Ray System Model Number: 100... Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of t... Class II Siemens Medical Solutions USA, Inc
Mar 19, 2021 Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTI... Siemens has become aware of a potential issue with software version VE20C. Planned procedures may... Class II Siemens Medical Solutions USA, Inc
Mar 10, 2021 Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System ... A patient image was assigned to a different patient during image recovery process. In the unlikel... Class II Siemens Medical Solutions USA, Inc
Mar 4, 2021 Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated... Due to the configuration of certain Windows Service Permissions within the operating systems of... Class II Siemens Medical Solutions USA, Inc
Mar 3, 2021 Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed t... SOMATOM systems-issues in with software syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a, may result in... Class II Siemens Medical Solutions USA, Inc
Feb 26, 2021 Interventional Fluoroscopic X-Ray System - Product Usage: developed for singl... Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces... Class II Siemens Medical Solutions USA, Inc
Feb 4, 2021 Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz... The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) int... Class II Siemens Medical Solutions USA, Inc.
Jan 27, 2021 Sensis / Sensis Vibe systems with software version VD12 and equipped with HP ... System may sporadically freeze (lock-up) during operation or while being in an idle state, no lon... Class II Siemens Medical Solutions USA, Inc
Dec 18, 2020 ARTIS Icono biplane Model:11327600 ARTIS Icono floor system Model: 11327700 ... Misleading error messages and a gap in the Operator Manual which affects ARTIS Icono biplane or A... Class II Siemens Medical Solutions USA, Inc
Nov 30, 2020 Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno When the user changes frame rates from lower frequency (e.g. 10 f/s) to higher frequency (e.g. 30... Class II Siemens Medical Solutions USA, Inc
Nov 24, 2020 SOMATOM Force, Definition AS, Definition Edge, Definition Flash, Drive, Conf... System does not trigger a cancel command followed by a reload of the scan with the new parameter(... Class II Siemens Medical Solutions USA, Inc
Oct 21, 2020 Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluo... Some electronic components within the generator were equipped with an incorrect protection diode.... Class II Siemens Medical Solutions USA, Inc
Sep 21, 2020 Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray ... Potential malfunction in which the examination room monitor may become intermittently dysfunction... Class II Siemens Medical Solutions USA, Inc
Sep 18, 2020 ARTIS Icono Interventional Fluoroscopic X-Ray system - Product Usage: Intende... There is a software problem which affects the DSA Roadmap application on ARTIS Icono and ARTIS Ph... Class II Siemens Medical Solutions USA, Inc
Sep 9, 2020 Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector... After the March 2019 corrective action on the monitor support arm, there is a residual risk of th... Class II Siemens Medical Solutions USA, Inc
Sep 9, 2020 Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector flu... After the March 2019 corrective action on the monitor support arm, there is a residual risk of th... Class II Siemens Medical Solutions USA, Inc
Aug 19, 2020 Software: Syngo.via RT Image Suite software version VA30_SP02 with license T_... Calibration offset between the central CT image plane and the external RT lasers has been set aut... Class II Siemens Medical Solutions USA, Inc
Aug 14, 2020 Symbia S-Series and Symbia T-Series - Product Usage: Intended use of the de... This letter is to inform you of the possibility that your Symbia S or Symbia T system(s) may have... Class II Siemens Medical Solutions USA, Inc.
Aug 3, 2020 Artis zee or Artis Q systems (listed below) - Product Usage: for single and b... Potential exists for the collision supervision not to work properly following loss of the individ... Class II Siemens Medical Solutions USA, Inc
Jul 30, 2020 Cios Alpha, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and... Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after... Class II Siemens Medical Solutions USA, Inc
Jul 30, 2020 Cios Spin, Image-Intensified Fluoroscopic X-Ray System The Cios Alpha and ... Siemens has become aware of a hardware error which affects Cios Spin and Cios Alpha systems after... Class II Siemens Medical Solutions USA, Inc
Jul 24, 2020 Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 modu... The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connec... Class II Siemens Medical Solutions USA, Inc
Jul 14, 2020 Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cio... Hardware error- Hot Plugging feature could cause an electrical malfunction on the main control D... Class II Siemens Medical Solutions USA, Inc
Jun 24, 2020 syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation ... Class II Siemens Medical Solutions USA, Inc
Jun 22, 2020 Software versions syngo.CT VB20 or VB20_SP1 in the following systems: SOMATO... Sporadic problems with the current software may result in scanning workflow interruptions and une... Class II Siemens Medical Solutions USA, Inc
May 22, 2020 ACUSON AcuNav Volume Intracardiac Echocardiography Catheter 12.5F Due to adverse events received by the firm for left atrial perforations and Atrioventricular Node... Class II Siemens Medical Solutions USA, Inc.
May 7, 2020 MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be us... If an examination is interrupted when the InSpect Projection View (PV) is active and the vacuum b... Class II Siemens Medical Solutions USA, Inc
Apr 30, 2020 Multi Display Manager in the Artis Systems (Image-Intensified Fluoroscopic X-... Artis systems containing a Multi Display Manager of a specific lot, the power distributor may lea... Class II Siemens Medical Solutions USA, Inc
Apr 23, 2020 ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standal... Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detectio... 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.