Varian Medical Systems, Inc
911 Hansen Way, PALO ALTO, CA, US
Registered product codes
5 product codes
Recent MDR events
379 on file
- TRUEBEAM LINEAR ACCELERATORJun 15, 2026MalfunctionMW5189447
- ONCOZENE MICROSPHERESMar 9, 2026MalfunctionMW5184945
- INTELLIBLATE XIMITRY PROBEFeb 3, 2026Injury3008262715-2026-00003
- INTELLIBLATE MICROWAVE ABLATION SYSTEM CONSOLEFeb 3, 2026Injury3008262715-2026-00004
- EMBOZENE MICROSPHERESJan 29, 2026Injury3008262715-2026-00002
- VARIAN TRUEBEAMNov 18, 2025InjuryMW5178975
- TRUEBEAMAug 11, 2025Malfunction22769851
- INTELLIBLATE XIMITRY PROBE ASSEMBLY, 13G X 15CMJun 9, 2025Malfunction22167328
- CLINAC IXMay 19, 2025MalfunctionMW5170576
- TRUEBEAMFeb 27, 2025Malfunction21478416
Recalls
124 on file
- TerminatedJan 10, 2017
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 conditions are fulfilled.
View FDA record ↗ - TerminatedOct 13, 2016
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
View FDA record ↗ - TerminatedJul 11, 2016
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 couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
View FDA record ↗ - TerminatedJul 11, 2016
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 couch rotation from the plan couch rotation while performing patient alignment with Optical Surface Monitoring System [OSMS].
View FDA record ↗ - TerminatedFeb 12, 2016
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 (MU). Potential for unintended radiation exposure.
View FDA record ↗ - TerminatedOct 30, 2015
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.
View FDA record ↗ - TerminatedJun 26, 2015
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 magnetic Hard Disk Drives (HDD).
View FDA record ↗ - TerminatedJun 23, 2015
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 of the applicator is approximately 14% higher than the rate published within the IFU. Use of the dose rate as provided by the IFU without modification or independent confirmat
View FDA record ↗ - TerminatedDec 16, 2014
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 stud on the lid of the High Voltage Module.
View FDA record ↗ - TerminatedSep 16, 2014
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 with BCCV.
View FDA record ↗
Compliance history
Matched by FEI 2916710.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.