Varian Medical Systems, Inc.
Complete recall history across all FDA and CPSC categories — 19 total recalls
Varian Medical Systems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (19)
FDA medical device enforcement actions by Varian Medical Systems, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| 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 becam... | Class II |
| 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] Prot... | Class II |
| 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 SmartSegment... | Class II |
| 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 r... | Class II |
| 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... | Class II |
| 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... | Class II |
| 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 wit... | Class II |
| 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 ... | Class II |
| 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 int... | Class II |
| 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 Energ... | Class II |
| 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 ... | Class II |
| 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... | Class II |
| 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 Parameter... | Class II |
| 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 h... | Class II |
| Aug 9, 2013 | VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INST... | The recall was initiated after Varian Medical became aware the Lexan template... | Class II |
| Apr 11, 2013 | Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed D... | Segmented cylinder applicator set may slip during treatment, causing the deli... | Class II |
| 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 diffic... | Class II |
| 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 ... | Class II |
| 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 ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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