Varian VitalBeam Radiotherapy Systems Recalled for Gating Anomaly
Varian Medical Systems is recalling VitalBeam Radiotherapy Delivery Systems due to a software anomaly that may result in treatment without intended respiratory gating.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a failure in respiratory gating could lead to unintended radiation delivery, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Varian Medical Systems is recalling four units of the VitalBeam Radiotherapy Delivery System Version 2.5. These systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
The recall is due to reports of an anomaly that can result in a treatment without intended gating, which is a form of respiratory tracking and monitoring. This issue occurs when a patient planned with gating is treated on more than one system. The affected software versions are 02.05.13.05 and 02.05.13.07.
The affected systems were distributed worldwide, including in the United States and numerous international countries. The source text does not specify specific actions for consumers or patients, but the recall is managed by the recalling firm, Varian Medical Systems.
The recalled product
- Product
- VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
- Manufacturer
- Varian Medical Systems
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- which includes TrueBeam
- TrueBeam STx
- VitalBeam and EDGE.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Varian Medical Systems under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Varian Medical Systems
See all →- HighVarian TrueBeam and EDGE Radiotherapy Systems Recalled for Gating Anomaly
FDA (Devices) · 2018-10-10
Same hazard · radiation exposure
See all →- HighPhilips Spectral CT 7500 Software Recall for Radiation Exposure Risk
FDA (Devices) · 2026-10-07
- HighPhilips Recalls IQon Spectral CT Systems Due to Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips Brilliance CT Systems Recalled for Unintended Radiation Issue
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
- HighPhilips CT Systems Recalled for Unintended Radiation Performance Issues
FDA (Devices) · 2026-09-09
Similar recalls
- ModerateVarian RPM Respiratory Gating System Recall for Waveform Anomaly
FDA (Devices) · 2013-05-01
- HighVision RT TrueBeam and Edge Radiotherapy Systems Recalled for Parameter Errors
FDA (Devices) · 2016-08-31
- SevereViewRay Patient Handling System Software Recalled for Unexpected Movement
FDA (Devices) · 2015-07-22
- HighVarian ARIA Radiation Oncology Software Recall Due to Treatment Plan Error
FDA (Devices) · 2012-11-07
- HighVarian Optical Surface Monitoring System Recall for Unintended Couch Parameter Changes
FDA (Devices) · 2016-07-20
- SevereViewRay Treatment Planning Software Recalled for Location Calculation Failure
FDA (Devices) · 2015-07-08