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.

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DateProductReasonClassFirm
Dec 8, 2016 Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis sys... Siemens initiated a corrective action to address two possible, mutually independent causes of a s... Class II Siemens Medical Solutions USA, Inc
Nov 22, 2016 SOMATOM Scope, Computed tomography x-ray system Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Conne... Class II Siemens Medical Solutions USA, Inc
Nov 22, 2016 SOMATOM Scope Power, Computed tomography x-ray system Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Conne... Class II Siemens Medical Solutions USA, Inc
Nov 22, 2016 SOMATOM Perspective, Computed tomography x-ray system Siemens is providing a new installation of the Residual Current Monitor (RCM) in the Line Connect... Class II Siemens Medical Solutions USA, Inc
Nov 15, 2016 SOMATOM Definition Flash System, x-ray, tomography, computed Intended to pro... Software update that provides software and firmware bug-fixes to improve system performance Class II Siemens Medical Solutions USA, Inc
Nov 15, 2016 SOMATOM Definition AS System, x-ray, tomography, computed Intended to produc... Software update that provides software and firmware bug-fixes to improve system performance Class II Siemens Medical Solutions USA, Inc
Nov 15, 2016 SOMATOM Definition Edge System, x-ray, tomography, computed Intended to prod... Software update that provides software and firmware bug-fixes to improve system performance Class II Siemens Medical Solutions USA, Inc
Nov 7, 2016 Z6Ms transesophageal transducers used on ACUSON SC2000 ultrasound systems, Z6... Firm received reports about "acquisition errors" and the deterioration of material covering the a... Class II Siemens Medical Solutions USA, Inc.
Nov 2, 2016 SOMATOM Definition AS, Computed tomography x-ray system The Siemens SOMATOM ... Siemens is releasing a software update that provides bug-fixes to improve system performance for ... Class II Siemens Medical Solutions USA, Inc
Nov 2, 2016 SOMATOM Definition Edge, Computed tomography x-ray system The Siemens SOMATO... Siemens is releasing a software update that provides bug-fixes to improve system performance for ... Class II Siemens Medical Solutions USA, Inc
Nov 2, 2016 SOMATOM Definition Flash, Computed tomography x-ray system The Siemens SOMAT... Siemens is releasing a software update that provides bug-fixes to improve system performance for ... Class II Siemens Medical Solutions USA, Inc
Nov 1, 2016 AXIOM Artis, Angiographic x-ray system Product Usage: The Artis systems ... The possibility exists that the semi-automatic focus switch may not work as intended when pressin... Class II Siemens Medical Solutions USA, Inc
Nov 1, 2016 Artis zee/zeego, Angiographic x-ray system Product Usage: The Artis syste... The possibility exists that the semi-automatic focus switch may not work as intended when pressin... Class II Siemens Medical Solutions USA, Inc
Nov 1, 2016 Artis Q, Angiographic x-ray system Product Usage: The Artis systems are a... The possibility exists that the semi-automatic focus switch may not work as intended when pressin... Class II Siemens Medical Solutions USA, Inc
Oct 20, 2016 SOMATOM Force, System x-ray, tomography, computed Siemens is providing software update version VA50A_SP3 to address the software bugs that were i... Class II Siemens Medical Solutions USA, Inc
Oct 19, 2016 SOMATOM Definition Flash system, x-ray, tomography, computed Hardware issue that may expose the user to a potential risk for serious injury due to exposure to... Class II Siemens Medical Solutions USA, Inc
Oct 19, 2016 SOMATOM Definition AS system, x-ray, tomography, computed Hardware issue that may expose the User to a potential risk for serious injury due to exposure to... Class II Siemens Medical Solutions USA, Inc
Oct 19, 2016 SOMATOM Definition AS, Computed tomography system Product Usage: SOMATOM ... A problem can occur with the small light marker windows, used for the positioning laser and are i... Class II Siemens Medical Solutions USA, Inc
Oct 19, 2016 SOMATOM Definition Flash, Computed tomography system Product Usage: SOMAT... A problem can occur with the small light marker windows, used for the positioning laser and are i... Class II Siemens Medical Solutions USA, Inc
Oct 17, 2016 Combi Dockable Neurosurgery table for the Siemens MAGNETOM Aera (1.5T) and Sk... Due to a potential manufacturing error, a rare possibility exists for a sudden drop in table heig... Class II Siemens Medical Solutions USA, Inc
Sep 6, 2016 Syngo.plaza VB10A, Picture Archiving and Communication System Software upgrade to eliminate several issues Class II Siemens Medical Solutions USA, Inc
Sep 6, 2016 Syngo.plaza, Picture Archiving and Communication System Software upgrade to eliminate several issues Class II Siemens Medical Solutions USA, Inc
Aug 5, 2016 Syngo.via picture archiving and communication system Syngo via is a softwa... Software error. Incorrect values for the volume calculation from a freehand VOI at the customer ... Class II Siemens Medical Solutions USA, Inc
Aug 5, 2016 e.cam and Symbia E gamma camera systems with patient beds To detect or ima... "We have received reports of patients hair being caught in the e.cam and Symbia E patient bed up... Class II Siemens Medical Solutions USA, Inc.
Aug 5, 2016 Syngo.x picture archiving and communication system Syngo.x is a software s... Software error. Incorrect values for the volume calculation from a freehand VOI at the customer ... Class II Siemens Medical Solutions USA, Inc
Aug 2, 2016 Syngo Plaza picture archiving and communication system (PAC) (PACS) intended ... Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows ... Class II Siemens Medical Solutions USA, Inc
Aug 2, 2016 Syngo.Plaza VB 10 A, image processing system (PACS) intended to display, proc... Siemens is releasing a Customer Advisory Notice to explain meaning of a suffix o.p. that shows ... Class II Siemens Medical Solutions USA, Inc
Aug 1, 2016 YSIO Max Product Usage: The Ysio Max is a radiographic system used in ho... Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion s... Class II Siemens Medical Solutions USA, Inc
Aug 1, 2016 Multix Fusion VA10 Product Usage: The Multix Fusion VA10 system is a radi... Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion s... Class II Siemens Medical Solutions USA, Inc
Aug 1, 2016 Multix Fusion Stationary X-Ray System Product Usage: The Multix Fusion sy... Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion s... Class II Siemens Medical Solutions USA, Inc
Jul 26, 2016 ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS brande... Software patch installation to address several safety issues. Class II Siemens Medical Solutions USA, Inc
Jul 26, 2016 PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerat... Software patch installation to address several safety issues. Class II Siemens Medical Solutions USA, Inc
Jul 26, 2016 Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a sof... Software patch installation to address several safety issues. Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 SOMATOM Definition Edge with software version VA48A-SP2; Model # 8098027 co... Due to an internal communication error between the firmware and the software of the components, t... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 SOMATOM Definition Flash with software version VA48A-SP2; Model # 10590000, c... Due to an internal communication error between the firmware and the software of the components, t... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM, system, x-ray, angiographic AXIOM Ar... The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 SOMATOM Definition AS with software version VA48A-SP2; Model # 10430603, co... Due to an internal communication error between the firmware and the software of the components, t... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 ARTIS ZEE AND ZEEGO, system, x-ray, angiographic AXIOM Artis, Artis zee / ze... The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... Class II Siemens Medical Solutions USA, Inc
Jul 13, 2016 ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM, interventional fluoroscopic ... The possibility exists for contaminants, in the form of biomass, to develop in the cooling system... Class II Siemens Medical Solutions USA, Inc
Jul 7, 2016 Artis zee/ zeego, Artis Q/ Q.zen, stand alone system, software controlled Mo... Due to an error in the 19 Live Display, image reproduction may fail in the examination room and ... Class II Siemens Medical Solutions USA, Inc
Jun 23, 2016 Syngo.via, picture archiving and communications system software controlled. ... Incorrect values for the volume calculation. Software update VB30B via Update Instructions SY018... Class II Siemens Medical Solutions USA, Inc
Jun 6, 2016 SYNGO Breast Care, visualization and image enhancement tools to aid radiolog... Software issues. Siemens is voluntarily initiating a recall after they became aware of the follow... Class II Siemens Medical Solutions USA, Inc
May 9, 2016 Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers... Software error in previous software versions in which two references for the same image may exist... Class II Siemens Medical Solutions USA, Inc
Apr 14, 2016 Syngo Dynamics; Kinetdx Picture Archiving and Communications System Siemens has identified changes in default carry forward workflow using VA10B_HF03 version of Syng... Class II Siemens Medical Solutions USA, Inc
Apr 13, 2016 MAGNETOM Aera/Skyra Systems, whole body magnetic resonance imaging systems, M... The docking station top cover of the removable patient table may contain a magnetic metal plate. ... Class II Siemens Medical Solutions USA, Inc
Apr 8, 2016 ACUSON SC2000 Ultrasound imaging system with software version VB10C and using... While imaging with a transesophageal (TEE) transducer (Z6Ms, V5Ms, or V7M), user may lose the abi... Class II Siemens Medical Solutions USA, Inc.
Apr 1, 2016 SOMATOM Force, Computed Tomography x-ray system intended to generate and ... The Neonate Head protocol with the pediatric kernel Hp38 could result in artefacts and possibly l... Class II Siemens Medical Solutions USA, Inc
Mar 31, 2016 E.cam or Symbia systems that use foresight detectors - Product Usage: To dete... E. CAM and Symbia system with foresight detectors performing gated or dynamic acquisition may los... Class II Siemens Medical Solutions USA, Inc.
Mar 22, 2016 SOMATOM Definition AS, a family of CT systems intended to produce cross-secti... Siemens became aware that the front cover on some Siemens CT system was not properly welded. It ... Class II Siemens Medical Solutions USA, Inc
Mar 11, 2016 Artis One, Interventional, Fluoroscopic, x-ray system Artis one is an angiog... After importing segmentation results of the left atrium created on the Artis One system, the poss... 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.