Viewray recalls specific MRIdian Linac models due to inadequate instructions for transferring radiation treatment plans between systems, potentially causing treatment errors. Affected units include Model 10000 and 20000 with listed serial numbers.
Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system.
Viewray is recalling certain MRIdian Linac Radiation Therapy Systems because the operator's manual and software don't provide clear instructions for transferring treatment plans between systems. This could lead to inconsistent radiation treatments if users try to switch systems without proper guidance.
The system lacks clear instructions for transferring treatment plans between different radiation therapy systems. Without proper guidance, healthcare providers might make errors when switching treatment regimens, potentially leading to inconsistent radiation doses for patients.
Healthcare providers using Viewray's MRIdian Linac Radiation Therapy Systems Model 10000 or 20000 with the listed serial numbers are most at risk. Patients receiving radiation therapy through these systems may experience inconsistent treatment if the transfer process is mishandled.
Check if your device is Model 10000 or 20000 with serial numbers listed in the recall notice (100-113, 201-225). The device listing numbers D158423 and D297999 are also associated with these models.
Identify if your device is Model 10000 or 20000 with the listed serial numbers (100-113, 201-225).
The recall occurs because the operator's manual and software do not provide adequate instructions for transferring radiation treatment plans between systems, which could lead to inconsistent treatments.
The recall does not include a specific remedy; you should check if your device is affected by reviewing the listed serial numbers and models.
The recall describes a potential for inconsistent treatment, but no specific injury mechanism is mentioned. This is considered low risk as it does not involve immediate physical harm.
We’ve drafted a message you can send Viewray to request your refund or repair — edit it as you like.
Subject: Recall Z-0676-2020 — Viewray Viewray Hello, I own a Viewray that is covered by recall Z-0676-2020 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.
