The Recall Desk
HighFDA (Devices)·Z-0005-2019·Announced 2018-10-10

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.

What this means for you

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
Category
Medical Device — Radiotherapy Equipment
Hazard
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

Distributed nationwide across the United States.

The notice also names 25 states specifically:

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 →

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