Varian Medical Systems recalls

Varian Medical Systems appears in 23 official U.S. recall notices indexed by RecallRadar, most recently on 2020-05-13.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recalls

• Varian Multileaf Collimator [MLC]
  FDA Device · Class II · 2020-05-13 · Varian Medical Systems
  Reason: After a recent upgrade to the collimator software version 8.5, the firm became aware that the multi-leaf collimator leaves did not move during an arc treatment. The issue is related to a transient carriage primary- seco…
• Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (E…
  FDA Device · Class II · 2019-01-30 · Varian Medical Systems
  Reason: There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-s…
• VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiothe…
  FDA Device · Class II · 2018-10-10 · Varian Medical Systems
  Reason: Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
• TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam…
  FDA Device · Class II · 2018-10-10 · Varian Medical Systems
  Reason: Reports have been received of an anomaly that can result in a treatment without intended gating (respiratory tracking/monitoring). This issue occurs when a patient planned with gating is treated on more than one system.
• Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiolog…
  FDA Device · Class II · 2017-01-18 · Varian Medical Systems
  Reason: Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain con…
• Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016)
  FDA Device · Class II · 2016-10-19 · Varian Medical Systems
  Reason: Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
• Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on Varian's TrueBeam EDGE
  FDA Device · Class II · 2016-07-20 · Varian Medical Systems
  Reason: Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different co…
• Optical Surface Monitoring System{Align RT Plus} This is used on Varian's TrueBeam EDGE
  FDA Device · Class II · 2016-07-20 · Varian Medical Systems
  Reason: Varian Medical Systems has received reports that unintended changes were made to planned couch parameters, specifically the couch rotation parameter, during patient set-up. This can occur when a user sets a different co…
• Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6
  FDA Device · Class II · 2016-02-24 · Varian Medical Systems
  Reason: When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units…
• ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License
  FDA Device · Class II · 2015-11-04 · Varian Medical Systems
  Reason: An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx.
• The VariSource iX series afterloader systems are computer controlled remote electro/mechanical systems used for medical purposes, for placi…
  FDA Device · Class II · 2015-07-08 · Varian Medical Systems
  Reason: After an application freeze and restart of the VariSource iX series by power cycling, the Partial Fraction generated by the system will not be correct. The application freeze issue affects only the systems equipped with…
• Surface Applicator Set with Leipzig-style Cone
  FDA Device · Class II · 2015-07-01 · Varian Medical Systems
  Reason: Varian has discovered that there is a discrepancy in the absolute dose rate given with the Leipzig-style Surface Applicator's Instructions for Use (IFU): Dose Characterization GM11010080 2012-09-06. The actual dose rate…
• Varian On-Board Imager Advanced Imaging System
  FDA Device · Class II · 2014-12-24 · Varian Medical Systems
  Reason: Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generators were shipped that are missing a ground wire between the EMIbraid on the induc­ tion assembly cable and the ground…
• 4D Integrated Treatment Console (4DITC), versions 10 and 11. 4DITC provided assistance for accurate treatment delivery by monitoring linear…
  FDA Device · Class II · 2014-09-24 · Varian Medical Systems
  Reason: Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used w…
• C-Series High Energy Linear Accelerator - Models: Novalis Tx, Trilogy, Trilogy Tx, Clinac iX, Clinac 2100 C/D, Clinac 2300C/D, Clinac 21EX,…
  FDA Device · Class II · 2014-09-24 · Varian Medical Systems
  Reason: Trend in reports of unexpected decrease in beam output in C-series High Energy Linear Accelerators for 6MV photon treatment mode.
• On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors
  FDA Device · Class II · 2014-04-30 · Varian Medical Systems
  Reason: Varian has identified a failure with the shaft of the Type 01 elbow motor for Exact arms used in the On-Board Imager (OBI) device due to belt over-tensioning.
• Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13
  FDA Device · Class II · 2014-01-01 · Varian Medical Systems
  Reason: An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may chang…
• C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator
  FDA Device · Class II · 2013-12-11 · Varian Medical Systems
  Reason: This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.
• VARISOURCE Breast Template System for high-dose rate Brachytherapy. ***INSTRUCTIONS FOR USE*** Breast Bridge & Template System AL13011000 *…
  FDA Device · Class II · 2013-10-30 · Varian Medical Systems
  Reason: The recall was initiated after Varian Medical became aware the Lexan templates of the Breast Bridge Template System could become bent and turn opaque after steam sterilization.
• Segmented Cylinder Applicator Set, Model # GM11004150, when used for Pulsed Dose Rate (PDR) Product Usage: Usage: Used during pulsed dose r…
  FDA Device · Class II · 2013-05-22 · Varian Medical Systems
  Reason: Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target.
• Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets
  FDA Device · Class II · 2013-02-06 · Varian Medical Systems
  Reason: A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
• Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets
  FDA Device · Class II · 2013-02-06 · Varian Medical Systems
  Reason: A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
• Segmented Cervix Applicator Set, part number GM11004310, a component used with the tube for segments and cervical sleeves The guide tube fo…
  FDA Device · Class II · 2012-12-26 · Varian Medical Systems
  Reason: The guide tube which is part of the Segmented Cervix Applicator Set is difficult to disconnect from cervical sleeve.