ViewRay recalls specific software versions for French, German, and Italian language settings in their MRIdian Linac System due to treatment delivery anomalies. Affected units may require software updates or corrections to ensure safe radiation therapy planning.
Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software.
ViewRay is recalling certain software versions for their MRIdian Linac System that have language-specific issues in French, German, and Italian. These software anomalies could affect the accuracy of radiation treatment planning if not corrected.
The software anomalies in French, German, and Italian language versions can cause errors in treatment delivery planning. This might lead to inaccurate radiation dosing during stereotactic radiosurgery or precision radiotherapy procedures.
Patients and medical professionals using ViewRay's MRIdian Linac System with specific software versions for French, German, or Italian language settings. Those with affected serial numbers are most at risk.
Check the serial number on your ViewRay MRIdian Linac System. French version affected serial numbers: 214, 215, 226, 240. German or Italian versions affected serial numbers: 203, 232, 108, 244.
Verify your software version by checking the serial number on the device. French versions with serial numbers 214, 215, 226, or 240 are affected. German or Italian versions with serial numbers 203, 232, 108, or 244 are affected.
French version affected serial numbers: 214, 215, 226, 240. German or Italian versions affected serial numbers: 203, 232, 108, 244.
No, the recall does not require stopping use. Affected units may need software updates to correct the language-specific anomalies.
The official recall does not specify a fix or remedy, so contact ViewRay directly for software updates or corrections.
We’ve drafted a message you can send ViewRay to request your refund or repair — edit it as you like.
Subject: Recall Z-1836-2021 — ViewRay ViewRay Hello, I own a ViewRay that is covered by recall Z-1836-2021 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.