ViewRay recalls its MRIdian Linac System (Model 20000) due to potential overheating of receive coil components that could cause burns. Affected units include all lots/serial numbers sold globally. No remedy specified in official notice.
There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user.
ViewRay is recalling its MRIdian Linac System (Model 20000) because components of the receive coil could overheat and cause burns to patients or users. This is a serious safety issue for medical facilities using the device for radiation treatments.
The receive coil components in the system can reach elevated temperatures during operation. This overheating poses a burn risk to both patients receiving treatment and medical staff handling the device.
Medical facilities that own or use the ViewRay MRIdian Linac System (Model 20000) are affected. Patients and staff at these facilities are at risk of burns from overheating components.
Check if your device has the model number 20000, CE marking, and rated supply voltage of 380/480 VAC. All lots and serial numbers are affected, so no specific identification is needed beyond the model.
Verify if your ViewRay MRIdian Linac System has the model number 20000, CE marking, and rated supply voltage of 380/480 VAC.
The official recall notice does not specify any remedy or fix for this issue.
All ViewRay MRIdian Linac Systems with model number 20000, CE marking, and rated supply voltage of 380/480 VAC are affected.
The device is not safe to use as it poses a burn risk due to potential overheating of components.
We’ve drafted a message you can send ViewRay to request your refund or repair — edit it as you like.
Subject: Recall Z-0482-2021 — ViewRay ViewRay Hello, I own a ViewRay that is covered by recall Z-0482-2021 from ViewRay. 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.
