Varian recalls VitalBeam radiotherapy systems version 2.5 due to potential treatment errors when patients with respiratory gating are moved between systems. Affected units have specific model numbers and were sold with certain software versions.
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 VitalBeam radiotherapy systems version 2.5 because treating patients with respiratory gating on more than one system can cause incorrect radiation treatment. This could lead to improper radiation delivery to the target area.
The hazard occurs when a patient planned for respiratory-gated treatment is moved to a different VitalBeam system during treatment. This can cause the system to deliver radiation without proper respiratory tracking, potentially affecting the treatment accuracy.
Patients receiving radiation therapy using VitalBeam version 2.5 systems are affected. Medical facilities using these systems for treatments with respiratory gating are most at risk.
Check for model numbers H192482, H192521, H192743, or H192816 on the system. VitalBeam version 2.5MR1 systems with software versions 02.05.13.05 or 02.05.13.07 are affected.
Identify your VitalBeam system model number to determine if it is affected by this recall.
Reach out to your radiation therapy provider for guidance on next steps and potential fixes.
The hazard is that treating a patient with respiratory gating on more than one VitalBeam system can cause incorrect radiation delivery.
Affected models include H192482, H192521, H192743, and H192816.
No, but you should check if your system is affected and contact your provider for guidance.
We’ve drafted a message you can send Varian to request your refund or repair — edit it as you like.
Subject: Recall Z-0005-2019 — Varian Varian Hello, I own a Varian that is covered by recall Z-0005-2019 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.
