ViewRay recalls its MRIdian System Model 10000 due to potential overheating of receive coil components that could cause burns during use. Affected units include all lots/serial numbers sold globally.
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 System Model 10000 because overheating components could cause burns to patients or users. This risk occurs during normal operation of the device.
The receive coil components may overheat during operation, creating a burn hazard for patients or users. This risk occurs when the system is in use for radiation therapy procedures.
Medical facilities using the ViewRay MRIdian System Model 10000 for radiation therapy are most at risk. Patients receiving treatment with this system could be affected.
Check for the Model No. 10000 with CE marking and rated supply voltage of 380/480 VAC. All lots and serial numbers are affected by this recall.
Verify the model number is 10000 with CE marking and rated supply voltage of 380/480 VAC.
Reach out to ViewRay directly for specific instructions on next steps for affected units.
Yes, patients receiving treatment with the ViewRay MRIdian System Model 10000 could be at risk of burns from overheating components.
Check for Model No. 10000 with CE marking and rated supply voltage of 380/480 VAC. All lots and serial numbers are affected.
Contact ViewRay directly for specific instructions on next steps for affected units.
We’ve drafted a message you can send ViewRay to request your refund or repair — edit it as you like.
Subject: Recall Z-0481-2021 — ViewRay ViewRay Hello, I own a ViewRay that is covered by recall Z-0481-2021 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.
