The Recall Desk
HighFDA (Devices)·Z-0004-2019·Announced 2018-10-10

Varian TrueBeam and EDGE Radiotherapy Systems Recalled for Gating Anomaly

Varian Medical Systems is recalling TrueBeam and EDGE radiotherapy systems because a software anomaly can cause treatments to occur 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 is classified as FDA Class II and involves a risk-of-harm product (radiotherapy delivery) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical or unreported harm in high-risk devices.

Plain-English summary

Varian Medical Systems is recalling 387 TrueBeam and EDGE Radiotherapy Delivery Systems, including versions 2.0 and 2.5, due to a reported anomaly. The issue involves the respiratory tracking or monitoring function, known as gating, which may fail to engage during treatment. This anomaly specifically occurs when a patient who was planned with gating is treated on more than one system.

The affected products are distributed worldwide, including in the United States and numerous international countries. The recall covers specific serial numbers and software versions for TrueBeam, TrueBeam STx, and TrueBeam EDGE systems. The FDA has classified this recall as Class II, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.

Healthcare facilities and users of these systems should contact Varian Medical Systems for instructions on how to address the issue. The recall is intended to prevent treatments from being delivered without the intended respiratory monitoring safeguards.

The recalled product

Product
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the
Manufacturer
Varian Medical Systems
Category
Medical Device — Radiotherapy Delivery System
Hazard
Affected units
387

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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