Viewray recalls its MRIdian Linac Radiation Therapy System Model 20000 due to potential dose calculation discrepancies between adaptive optimizations and AQA calculations. Affected units have specific serial numbers listed in the recall.
A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur.
Viewray is recalling its MRIdian Linac Radiation Therapy System Model 20000 because of a potential discrepancy in radiation dose calculations between adaptive treatments and quality assurance checks. This could affect treatment accuracy for cancer patients.
The system may show a difference in radiation dose calculations between treatment planning and actual delivery. This discrepancy could lead to incorrect radiation doses being delivered during cancer treatment, potentially affecting treatment effectiveness or safety.
Patients receiving radiation therapy using this specific model of Viewray system are affected. Medical facilities that use the Model 20000 for cancer treatment are most at risk.
Check if your Viewray MRIdian Linac Radiation Therapy System has the Model 20000 with serial numbers listed: 101, 107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
Verify your device's serial number against the list: 101, 107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
The Model 20000 MRIdian Linac Radiation Therapy System.
The system may deliver incorrect radiation doses during cancer treatment, potentially affecting treatment effectiveness or safety.
Check your device's serial number against the list: 101, 107, 201, 202, 203, 204, 205, 206, 209, 211, 213, 214, 217, 221, 223, 225, 228.
We’ve drafted a message you can send Viewray to request your refund or repair — edit it as you like.
Subject: Recall Z-1251-2019 — Viewray Viewray Hello, I own a Viewray that is covered by recall Z-1251-2019 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.
