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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Date	Product	Reason	Class	Firm
May 28, 2019	SOMATOM go.Top (Model #1161640), with syngo.CT software versions VA20A, VA20A...	The potential sporadic performance problems may result in scanning workflow interruptions and une...	Class II	Siemens Medical Solutions USA, Inc
May 28, 2019	SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20...	The potential sporadic performance problems may result in scanning workflow interruptions and une...	Class II	Siemens Medical Solutions USA, Inc
May 28, 2019	SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_...	The potential sporadic performance problems may result in scanning workflow interruptions and une...	Class II	Siemens Medical Solutions USA, Inc
Apr 9, 2019	Artis Zee (material # 10094135, 10094137, 10094141) - Product Usage: AXIOM Ar...	In affected Artis systems the movement of the floating tabletop may be blocked after a collision ...	Class II	Siemens Medical Solutions USA, Inc
Apr 9, 2019	Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis ...	In affected Artis systems the movement of the floating tabletop may be blocked after a collision ...	Class II	Siemens Medical Solutions USA, Inc
Apr 9, 2019	Artis Q (material 10848280, 10848281, 10848282) - Product Usage: AXIOM Artis ...	In affected Artis systems the movement of the floating tabletop may be blocked after a collision ...	Class II	Siemens Medical Solutions USA, Inc
Apr 9, 2019	Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen...	In affected Artis systems the movement of the floating tabletop may be blocked after a collision ...	Class II	Siemens Medical Solutions USA, Inc
Mar 22, 2019	Cios Alpha with software version VA30-mobile C-arm x-ray Material # 11105200...	Continuous operation of the Cios Alpha at high tube outputs may result in increased wear of radia...	Class II	Siemens Medical Solutions USA, Inc
Mar 21, 2019	syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: ...	There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning proc...	Class II	Siemens Medical Solutions USA, Inc
Mar 21, 2019	syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: ...	There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning proc...	Class II	Siemens Medical Solutions USA, Inc
Mar 20, 2019	Siemens Digital Linear Accelerators of type: ARTISTE MV System MEVATRON M2/...	Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP functio...	Class II	Siemens Medical Solutions USA, Inc
Mar 18, 2019	Cios Alpha, Model Number 10308191 Mobile X-ray system - Product Usage: The C...	Continuous operation at very high tube output may result in increased wear of the radiation emitt...	Class II	Siemens Medical Solutions USA, Inc
Feb 14, 2019	SOMATOM Edge Plus, Model Number 10267000 Product Usage: Computed tomograp...	Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to...	Class II	Siemens Medical Solutions USA, Inc
Feb 14, 2019	SOMATOM Definition Edge, Model Number 10590000 Product Usage: Computed to...	Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to...	Class II	Siemens Medical Solutions USA, Inc
Feb 14, 2019	SOMATOM Confidence, Model Number 10590100 Product Usage: Computed tomogra...	Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to...	Class II	Siemens Medical Solutions USA, Inc
Feb 14, 2019	SOMATOM Definition AS with Option syngo DE Scan for Single Source (Dual Spira...	Potential risk of scans being aborted when using the optional Dual Spiral Dual Engery mode due to...	Class II	Siemens Medical Solutions USA, Inc
Feb 8, 2019	Uroskop Omnia -fluoroscopic X-ray system Model # 10094910 The Uroskop Omn...	The swivel arm holding the monitors may become dislodged from the carrying arm.	Class II	Siemens Medical Solutions USA, Inc
Feb 8, 2019	Uroskop Omnia Max -fluoroscopic X-ray system Model # 10762473 Uroskop Om...	The swivel arm holding the monitors may become dislodged from the carrying arm.	Class II	Siemens Medical Solutions USA, Inc
Jan 28, 2019	ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens M...	The action is being initiated due to internal testing which identified a possibility for transduc...	Class II	Siemens Medical Solutions USA, Inc.
Jan 28, 2019	ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Si...	The action is being initiated due to internal testing which identified a possibility for transduc...	Class II	Siemens Medical Solutions USA, Inc.
Jan 28, 2019	ACUSON NX3 Diagnostic Ultrasound System, Model # 11235612, RX Only, Siemens ...	The action is being initiated due to internal testing which identified a possibility for transduc...	Class II	Siemens Medical Solutions USA, Inc.
Jan 28, 2019	ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Sie...	The action is being initiated due to internal testing which identified a possibility for transduc...	Class II	Siemens Medical Solutions USA, Inc.
Nov 30, 2018	Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biogr...	Improper design or specifications.	Class II	Siemens Medical Solutions USA, Inc.
Nov 29, 2018	Sensis Vibe System, Model Number 11007642, with software version VD10B.	A software error may result in a system crash. The system must be restarted before the clinical ...	Class II	Siemens Medical Solutions USA, Inc
Oct 26, 2018	Artis Zee and Zeego, model no. 10272462 AXIOM Artis zee/Zeego is a family ...	This recall has been initiated due to a possible leakage of a hose in the cooling unit of the X-r...	Class II	Siemens Medical Solutions USA, Inc
Oct 19, 2018	ARTIS zee biplane systems with Material 10094141- a Angiographic x-ray system...	Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw co...	Class II	Siemens Medical Solutions USA, Inc
Oct 19, 2018	ARTIS Q.zen biplane with Material 10848355 - a Angiographic x-ray system ...	Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw co...	Class II	Siemens Medical Solutions USA, Inc
Oct 19, 2018	ARTIS Q biplane with Material 10848282- - a Angiographic x-ray system Pro...	Vibrations of the C-arm of the plane B may result in reduced image quality caused by the screw co...	Class II	Siemens Medical Solutions USA, Inc
Oct 5, 2018	EVO Excel, Emission Computed Tomographic System, Material Number 10910501	The Evo Excel External-ECG Power-Connection current limit is mis-labeled as 1.0A. It should be l...	Class II	Siemens Medical Solutions USA, Inc.
Sep 28, 2018	Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 105...	The terminals on the plug may become loose and overheat.	Class II	Siemens Medical Solutions USA, Inc.
Sep 28, 2018	Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material...	The terminals on the plug may become loose and overheat.	Class II	Siemens Medical Solutions USA, Inc.
Aug 6, 2018	AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table...	In rare cases of high clinical workload, the steel cables inside the lifting column of the overhe...	Class II	Siemens Medical Solutions USA, Inc
Aug 6, 2018	Ysio (model number 10281013 or 10281163) with Tube stand 3D V (model number 7...	In rare cases of high clinical workload, the steel cables inside the lifting column of the overhe...	Class II	Siemens Medical Solutions USA, Inc
Aug 6, 2018	Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 o...	In rare cases of high clinical workload, the steel cables inside the lifting column of the overhe...	Class II	Siemens Medical Solutions USA, Inc
Aug 3, 2018	Multix Fusion system is a radiographic system: Models: Multix Fusion Analog...	Steel cables inside the lifting column of the overhead tube, may rapture without triggering the ...	Class II	Siemens Medical Solutions USA, Inc
Jul 29, 2018	Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 108...	Temperature of the detector may fall out of its designed working range (cool down) due to incorre...	Class II	Siemens Medical Solutions USA, Inc
Jul 29, 2018	ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model Number 10849000	Temperature of the detector may fall out of its designed working range (cool down) due to incorre...	Class II	Siemens Medical Solutions USA, Inc
Jun 29, 2018	3D TOP Ceiling Stand, model no. 3070039 3074486 3070013 3070021 Product...	In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceilin...	Class II	Siemens Medical Solutions USA, Inc
Jun 29, 2018	3D V, model. no. 7042042 7042059 3070021 Product Usage: The ceiling...	In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceilin...	Class II	Siemens Medical Solutions USA, Inc
Jun 22, 2018	Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10...	Potential hardware issue which may cause thermal effects and possible damage to system parts.	Class II	Siemens Medical Solutions USA, Inc
Jun 22, 2018	ARTIS Pheno Model 10849000. Interventional Fluoroscopic X-Ray System Produ...	Potential hardware issue which may cause thermal effects and possible damage to system parts.	Class II	Siemens Medical Solutions USA, Inc
May 30, 2018	ARTIS Pheno, Fluoroscopic X-Ray system, Model Number 10849000	During manual LAO/RAO rotation at maximum speed or a combination of LAO/RAO and Cran/Caud rotatio...	Class II	Siemens Medical Solutions USA, Inc
May 29, 2018	Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 ...	Siemens Medical Solutions USA, Inc., Molecular Imaging business line became aware, through our su...	Class II	Siemens Medical Solutions USA, Inc.
May 25, 2018	Artis zee systems with Laird Cooling Unit for SSFD: Material # 7555118. Art...	Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w...	Class II	Siemens Medical Solutions USA, Inc
May 25, 2018	AXIOM Artis with Laird Cooling Unit for SSFD: Material # 7555118. Artis is ...	Due to a defective sealing, coolant may inflow into the electrical parts of the system cabinet, w...	Class II	Siemens Medical Solutions USA, Inc
May 1, 2018	Artis zee floor MN, Material no. 10094142, for angiography and whole body rad...	After the Large Display returns from power save mode, it may not show an image, and stay black wi...	Class II	Siemens Medical Solutions USA, Inc
May 1, 2018	Artis Q.zen biplane, Material no. 10848355, for angiography and whole body ra...	After the Large Display returns from power save mode, it may not show an image, and stay black wi...	Class II	Siemens Medical Solutions USA, Inc
May 1, 2018	Artis zee floor, Material no. 10094135, for angiography and whole body radiog...	After the Large Display returns from power save mode, it may not show an image, and stay black wi...	Class II	Siemens Medical Solutions USA, Inc
May 1, 2018	Artis zee ceiling, Material no. 10094137, for angiography and whole body radi...	After the Large Display returns from power save mode, it may not show an image, and stay black wi...	Class II	Siemens Medical Solutions USA, Inc
May 1, 2018	Artis zee biplane, Material no. 10094141, for angiography and whole body radi...	After the Large Display returns from power save mode, it may not show an image, and stay black wi...	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.