Browse Device Recalls

28 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 28 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 28 FDA device recalls.

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Date	Product	Reason	Class	Firm
Aug 12, 2019	Varian Multileaf Collimator [MLC]; Millenium Multileaf Collimator [52, 80, 12...	After a recent upgrade to the collimator software version 8.5, the firm became aware that the mul...	Class II	Varian Medical Systems, Inc.
Dec 26, 2018	Eclipse(TM) Treatment Planning System with Proton Convolution Superposition a...	There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Super...	Class II	Varian Medical Systems, Inc.
Dec 2, 2016	Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmen...	Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces res...	Class II	Varian Medical Systems, Inc.
Sep 13, 2016	Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and P...	Varian Medical Systems has received a report that a user was able to easily rotate the head frame...	Class II	Varian Medical Systems, Inc.
Jun 23, 2016	Optical Surface Monitoring System{Align RT Plus} This is used on Varian's Tru...	Varian Medical Systems has received reports that unintended changes were made to planned couch p...	Class II	Varian Medical Systems, Inc.
Jun 23, 2016	Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on...	Varian Medical Systems has received reports that unintended changes were made to planned couch pa...	Class II	Varian Medical Systems, Inc.
Jan 11, 2016	Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model nu...	When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segm...	Class II	Varian Medical Systems, Inc.
Sep 28, 2015	ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assess...	An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessmen...	Class II	Varian Medical Systems, Inc.
Aug 18, 2014	4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provi...	Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by th...	Class II	Varian Medical Systems, Inc.
Jun 17, 2014	C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilog...	Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerator...	Class II	Varian Medical Systems, Inc.
Apr 30, 2014	Varian On-Board Imager Advanced Imaging System. The On-Board Imager device...	Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generat...	Class II	Varian Medical Systems, Inc.
Mar 20, 2014	On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type...	Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in ...	Class II	Varian Medical Systems, Inc.
Nov 18, 2013	Plan Parameters workspace within Eclipse Treatment Planning System Version 1...	An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a ...	Class II	Varian Medical Systems, Inc.
Oct 24, 2013	C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelera...	This correction is to notify users that a solution to a previous correction has been developed an...	Class II	Varian Medical Systems, Inc.
Aug 9, 2013	VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INST...	The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Brid...	Class II	Varian Medical Systems, Inc.
Apr 11, 2013	Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed D...	Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to...	Class II	Varian Medical Systems, Inc.
Mar 26, 2013	Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option,...	Varian has identified an anomaly with the RPM Respiratory Gating System version I.7.5 with 3D Op...	Class II	Varian Medical Systems, Inc. Oncology Systems
Jan 28, 2013	Varian Eclipse Treatment Planning System for Radiotherapy; Model Number: H48....	The calculation of dose dynamic plans containing different energy fields is incorrect when the Pe...	Class II	Varian Medical Systems, Inc. Oncology Systems
Nov 5, 2012	Varian brand ARIA Radiation Oncology, ARIA Oncology Information System Radiat...	Varian Medical Systems has identified an anomaly with the ARIA Oncology Information System Radiat...	Class II	Varian Medical Systems, Inc. Oncology Systems
Sep 28, 2012	Segmented Cervix Applicator Set, part number GM11004310, a component used wit...	The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect fr...	Class II	Varian Medical Systems, Inc.
Sep 24, 2012	ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. T...	An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor...	Class II	Varian Medical Systems, Inc. Oncology Systems
Aug 17, 2012	Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8....	Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned H...	Class II	Varian Medical Systems, Inc. Oncology Systems
Aug 14, 2012	Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model ...	Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can c...	Class II	Varian Medical Systems, Inc. Oncology Systems
Jul 2, 2012	Varian brand Varian ARIA Oncology Information System, Import Export applicat...	A software anomaly has been identified with the Import Export Application version 11.0 where MLC...	Class II	Varian Medical Systems, Inc. Oncology Systems
Jun 18, 2012	Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model...	Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments...	Class II	Varian Medical Systems, Inc. Oncology Systems
Apr 12, 2012	Rectal Retractors, stainless steel, item # AL07289000, a component of Varian...	A medical device used in brachytherapy may become contaminated and can cause infections, toxicity...	Class II	Varian Medical Systems, Inc.
Apr 12, 2012	Rectal Retractors, titanium, item # AL07368000, a component of Varian Medica...	A medical device used in brachytherapy may become contaminated and can cause infections, toxicity...	Class II	Varian Medical Systems, Inc.
May 31, 2011	Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment Syst...	Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in ...	Class II	Varian Medical Systems, Inc. Oncology Systems

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.