Varian recalls TrueBeam and TrueBeam STx radiotherapy systems with version 2.0 and 2.5 software to prevent treatment without intended respiratory gating. Affected units have specific serial numbers and model codes.
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.
Varian is recalling specific versions of their TrueBeam and TrueBeam STx radiotherapy systems. The issue can cause treatments to happen without proper respiratory tracking, potentially leading to incorrect radiation delivery. This affects medical facilities using these systems for cancer treatment.
The recall addresses an anomaly where treatments planned with respiratory gating can be delivered without the intended gating mechanism. This occurs when a patient is treated on more than one system, potentially leading to incorrect radiation delivery and treatment outcomes.
Medical facilities that own or use TrueBeam or TrueBeam STx radiotherapy systems with specific software versions and serial numbers listed in the recall. Patients receiving treatment with these systems may be at risk of incorrect radiation delivery.
Check for TrueBeam or TrueBeam STx systems with software versions 2.0 or 2.5 (including MR1 updates) and specific serial numbers listed in the recall document. The product codes start with H19 and include model identifiers like TRUEBEAM or TRUEBEAM STX.
Verify the software version on your TrueBeam or TrueBeam STx system to confirm if it matches the affected versions listed in the recall.
Reach out to Varian Medical Systems directly to confirm if your specific system is affected and to receive instructions for next steps.
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.
Check for TrueBeam or TrueBeam STx systems with software versions 2.0 or 2.5 (including MR1 updates) and specific serial numbers listed in the recall document. The product codes start with H19 and include model identifiers like TRUEBEAM or TRUEBEAM STX.
No, the recall does not require immediate discontinuation of use. Medical facilities should verify their system's software version and contact Varian for specific instructions.
We’ve drafted a message you can send Varian to request your refund or repair — edit it as you like.
Subject: Recall Z-0004-2019 — Varian Varian Hello, I own a Varian that is covered by recall Z-0004-2019 from Varian. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
