Browse Device Recalls

88 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 88 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 88 FDA device recalls.

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Date	Product	Reason	Class	Firm
Jul 31, 2015	Siemens Symbia S Series system, a diagnostic analog or digital detector based...	Fuses with the improper amperage rating were installed in the Symbia S, Symbia T Series and Symbi...	Class II	Siemens Medical Solutions USA, Inc.
Jun 29, 2015	ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or 6C1 HD biopsy...	When using the CIVCO biopsy attachments in combination with the ACUSON S Family on-screen guideli...	Class II	Siemens Medical Solutions USA, Inc.
Jun 26, 2015	e.cam Gamma Camera, an emission computed tomography system. It is intended to...	Potential failure mode related to the radial brake, where the detector was able to drift, led to ...	Class II	Siemens Medical Solutions USA, Inc.
Jun 25, 2015	ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ op...	Potential measurement error on ACUSON S Family ultrasound system. When repositioning the Virtual ...	Class II	Siemens Medical Solutions USA, Inc.
Jun 25, 2015	ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with softw...	Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual t...	Class II	Siemens Medical Solutions USA, Inc.
May 29, 2015	ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A an...	When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of d...	Class II	Siemens Medical Solutions USA, Inc.
Jan 12, 2015	ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. ...	There is a low probability the scanner arm will become completely detached from the scanner column.	Class II	Siemens Medical Solutions USA, Inc.
Jan 12, 2015	ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. ...	The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Cont...	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	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.
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.
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 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 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.
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	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.
Dec 22, 2013	ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 H...	The user interface assembly on the ACUSON SC2000 may become loose with the potential for the ent...	Class II	Siemens Medical Solutions USA, Inc.
Dec 22, 2013	ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical ...	The locking mechanism that is intended to hold the control panel in a fixed position can become l...	Class II	Siemens Medical Solutions USA, Inc.
Oct 28, 2013	Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient c...	Reports of loose bolts in the detector support structure of Symbia and E.CAM systems.	Class II	Siemens Medical Solutions USA, Inc.
Oct 28, 2013	e.cam line of gamma camera systems Used to detect or image the distributi...	Reports of loose bolts in the detector support structure of Symbia and e.cam systems.	Class II	Siemens Medical Solutions USA, Inc.
Aug 16, 2013	Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the...	The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally an...	Class II	Siemens Medical Solutions USA, Inc.
Aug 16, 2013	Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of r...	The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally an...	Class II	Siemens Medical Solutions USA, Inc.
Jul 10, 2013	Acuson SC2000 volume imaging ultrasound systems at software version 3.0. M...	Software issue results in inaccurate 3D image may result in ablation in wrong location.	Class II	Siemens Medical Solutions USA, Inc.
Mar 28, 2013	Siemens brand ACUSON SC2000 Ultrasound System, Model 10433816, hardware that ...	When using the V5M transducer, the display of the temperature on the ACUSON SC2000 system can be ...	Class II	Siemens Medical Solutions USA, Inc.
Jan 18, 2013	ACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 ...	On some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.	Class II	Siemens Medical Solutions USA, Inc.
Oct 23, 2012	The Siemens Symbia T series is intended to aid in detecting, localizing, diag...	There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.	Class II	Siemens Medical Solutions USA, Inc.
Oct 23, 2012	The Siemens Symbia S series is intended to aid in detecting, localizing, diag...	There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.	Class II	Siemens Medical Solutions USA, Inc.
Jul 11, 2012	ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model ...	In certain situations, loss of post exercise images can occur in Stress Echo.	Class II	Siemens Medical Solutions USA, Inc.
May 11, 2012	ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, V...	In some cases, the system is unable to capture a clip or image during a routine scan.	Class II	Siemens Medical Solutions USA, Inc.
Apr 11, 2012	Symbia E is a multi-purpose SPECT system used to detect or image the distribu...	Radial motor drives replaced during a customer service action were incorrectly assembled backwards.	Class II	Siemens Medical Solutions USA, Inc.
Apr 11, 2012	E.CAM emission computed tomography system used to detect or image the distrib...	Radial motor drives replaced during a customer service action were incorrectly assembled backwards.	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.