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
Nov 19, 2014	ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The...	There may be an existing dark current phenomenon on ARTISTE LINAC in combination with IMRT or mAR...	Class II	Siemens Medical Solutions USA, Inc
Nov 11, 2014	Syngo.plaza, Syngo.plaza VB10A, and syngo Imaging XS : Product Usage: ...	Printouts may be printed in incorrect anatomical size when using syngo.plaza or syngo Imaging XS ...	Class II	Siemens Medical Solutions USA, Inc
Oct 28, 2014	Mammomat Inspiration system: Product Usage: mammography exams, screening...	It was determined that if the Mammomat Inspiration system is not secured to the floor (per custom...	Class II	Siemens Medical Solutions USA, Inc
Oct 10, 2014	Siemens SimView NT and SimView NT with IDI simulation system components: ...	Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simul...	Class II	Siemens Medical Solutions USA, Inc
Sep 23, 2014	Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : A...	A cable inside the C-arm systems may have been routed in an inappropriate manner. Improper routi...	Class II	Siemens Medical Solutions USA, Inc
Sep 18, 2014	Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiratio...	The stereo biopsy devices for Mammomat Inspiration mammography systems might have integrated a sa...	Class II	Siemens Medical Solutions USA, Inc
Sep 17, 2014	Artis zee/ zeego systems, model numbers: 10094135, 10094137, 10094139, 10094...	The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not b...	Class II	Siemens Medical Solutions USA, Inc
Sep 2, 2014	Siemens Ysio Max system The Ysio Max is a radiographic system used in hospit...	Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L...	Class II	Siemens Medical Solutions USA, Inc
Sep 2, 2014	Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detecto...	Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L...	Class II	Siemens Medical Solutions USA, Inc
Sep 2, 2014	Siemens Luminos Agile Max system The Luminos Agile is intended to be used a...	Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L...	Class II	Siemens Medical Solutions USA, Inc
Sep 2, 2014	Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to...	Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM L...	Class II	Siemens Medical Solutions USA, Inc
Aug 27, 2014	The Ysio Systems with software version VC10 The Ysio enables radiographic ...	Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the...	Class II	Siemens Medical Solutions USA, Inc
Aug 13, 2014	V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (...	Reports of deterioration of material covering the articulating section of the V5Ms transesophagea...	Class II	Siemens Medical Solutions USA, Inc.
Aug 12, 2014	The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support ...	Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec...	Class II	Siemens Medical Solutions USA, Inc.
Aug 12, 2014	The Siemens Symbia T series is intended for use by appropriately trained heal...	Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec...	Class II	Siemens Medical Solutions USA, Inc.
Aug 12, 2014	AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Lum...	It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 o...	Class II	Siemens Medical Solutions USA, Inc
Aug 12, 2014	The Siemens Symbia S series is intended for use by appropriately trained heal...	Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec...	Class II	Siemens Medical Solutions USA, Inc.
Jul 28, 2014	The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. Th...	Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected...	Class II	Siemens Medical Solutions USA, Inc.
Jul 28, 2014	The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrat...	Siemens Medical Solutions USA, Inc. is performing a field correction because we recently detected...	Class II	Siemens Medical Solutions USA, Inc.
Jul 7, 2014	Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF ...	It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia ...	Class II	Siemens Medical Solutions USA, Inc
Jun 30, 2014	Siemens syngo Imaging XS, version VA70A or higher Syngo Imaging XS is a Pi...	Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A ...	Class II	Siemens Medical Solutions USA, Inc
Jun 17, 2014	Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMEN...	Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncolo...	Class II	Siemens Medical Solutions USA, Inc
Jun 5, 2014	AXIOM Artis or Artis zee system Product Usage: Axiom Artis and Artis zee /...	There is a potential problem with the AXIOM Artis or Artis zee system in connection with the hand...	Class II	Siemens Medical Solutions USA, Inc
Jun 5, 2014	Artis zee and Artis zeego systems. x-ray, angiographic system	There is a potential problem with Artis zee and Artis zeego systems running software version VC21...	Class II	Siemens Medical Solutions USA, Inc
Jun 3, 2014	ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30...	There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on ...	Class II	Siemens Medical Solutions USA, Inc.
May 28, 2014	Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic...	A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field...	Class II	Siemens Medical Solutions USA, Inc
May 15, 2014	Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use o...	An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address ...	Class II	Siemens Medical Solutions USA, Inc
May 9, 2014	Siemens Mobilett XP Digital Mobile X-ray System Product Usage: The Mobil...	There is a potential fire hazard of certain Lithium-Ion batteries in the computers used in the or...	Class II	Siemens Medical Solutions USA, Inc
May 9, 2014	Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems ar...	Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generato...	Class II	Siemens Medical Solutions USA, Inc
May 6, 2014	Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; L...	There is a potential risk when using LANTIS OIS System client software with operating systems for...	Class II	Siemens Medical Solutions USA, Inc
Apr 25, 2014	MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis...	There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monit...	Class II	Siemens Medical Solutions USA, Inc
Apr 24, 2014	MAGNETOM Aera magnetic resonance system. Indicated for use as a magnetic r...	Siemens discovered a processing error for the MAGNETOM Aera magnetic resonance system that may ha...	Class II	Siemens Medical Solutions USA, Inc
Apr 23, 2014	Symbia E camera system. Emission Computed Tomography System used to detect o...	Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear cast...	Class II	Siemens Medical Solutions USA, Inc.
Apr 23, 2014	ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using S...	Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software...	Class II	Siemens Medical Solutions USA, Inc.
Apr 23, 2014	ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasoun...	Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly...	Class II	Siemens Medical Solutions USA, Inc.
Apr 23, 2014	e.cam camera system. Emission Computed Tomography System used to detect or i...	Siemens Medical Solutions USA, Inc. has received reports indicating the collimator cart rear cast...	Class II	Siemens Medical Solutions USA, Inc.
Apr 11, 2014	AXIOM Luminos dRFsystem The Axiom Luminos dRF is intended to be used as a...	It was determined that under rare environmental conditions (i.e., extremely dry air in combinatio...	Class II	Siemens Medical Solutions USA, Inc
Apr 8, 2014	e.cam -emission computed tomography system Used to detect or image the dis...	There is a potential for patient finger injury on the e.cam systems.	Class II	Siemens Medical Solutions USA, Inc.
Apr 3, 2014	syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication...	A complaint reported that the archiving method at one customer site was changed from implicit to ...	Class II	Siemens Medical Solutions USA, Inc
Apr 3, 2014	Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PA...	Systems with the affected serial number are experiencing a software error which may lead to incor...	Class II	Siemens Medical Solutions USA, Inc
Apr 2, 2014	Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, ...	When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are use...	Class II	Siemens Medical Solutions USA, Inc.
Apr 1, 2014	550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliv...	Table may lose calibration during patient treatment, which may cause the possibility of mistreatm...	Class II	Siemens Medical Solutions USA, Inc
Apr 1, 2014	Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray ...	Siemens Radiation Oncology became aware that customers may be using the Siemens Linear Accelerato...	Class II	Siemens Medical Solutions USA, Inc
Mar 21, 2014	Siemens SOMATOM Emotion 16, Emotion 6, and SOMATOM Spirit Computed Tomography...	The rubber damper may degrade and break, causing loosening of the motor mounting plates, which co...	Class II	Siemens Medical Solutions USA, Inc
Mar 7, 2014	Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E c...	ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includ...	Class II	Siemens Medical Solutions USA, Inc.
Mar 5, 2014	AXIOM Vertix MD Trauma systems radiographic X-ray	There is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma ...	Class II	Siemens Medical Solutions USA, Inc
Mar 5, 2014	Symbia T and Symbia T2 computer tomography systems. These systems are used to...	There are confirmed reports of a component coming loose inside the CT enclosure and damaging the ...	Class II	Siemens Medical Solutions USA, Inc.
Feb 13, 2014	MULTIX FUSION. The Multix Fusion system is a radiographic system used in h...	It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system bec...	Class II	Siemens Medical Solutions USA, Inc
Feb 7, 2014	AXIOM Artis Systems Product usage: Artis zee is a family of dedicated ang...	Certain units of the AXIOM Artis Systems are using a flat detector cooling unit with inappropriat...	Class II	Siemens Medical Solutions USA, Inc
Feb 7, 2014	Artis Zee Angiographic x-ray systems.	An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a ...	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.