ViewRay System models 10000 and 20000 for radiation treatment may have misalignment in dose registration causing incorrect radiation doses. Affected units include specific serial numbers listed in the recall notice.
Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows this misalignment to the user in the predicted dose-volume histogram (DVH). The misalignment impact may not be obvious to the user. During plan re-optimization the previously delivered dose would be incorrectly accounted for by the software. This may result in unexpectedly higher or lower dose than the intended dose calculated for the subsequent treatment plan. When this occurs in the treatment planning workflow, the registration fails to align the dose with the image and the user is unable to proceed.
ViewRay's radiation treatment systems (models 10000 and 20000) may misalign radiation doses during treatment planning, potentially delivering incorrect radiation levels. This could lead to unintended higher or lower radiation doses than intended, risking patient safety.
The software may misalign previously delivered radiation doses with current patient anatomy during treatment planning. This misalignment can cause the system to incorrectly account for radiation doses during plan re-optimization, potentially delivering higher or lower radiation than intended.
Patients receiving radiation therapy using ViewRay systems with the specified model numbers and serial numbers are most at risk. Healthcare providers using these systems for treatment planning may also be affected.
Check if your ViewRay system has model numbers 10000 or 20000 with the listed serial numbers. The recall covers specific units identified by these model and serial number combinations.
Identify your ViewRay system's model number (10000 or 20000) and serial numbers to determine if it is affected.
Reach out to ViewRay, Inc. for further guidance on the recall and potential remedies.
The recall affects ViewRay System models 10000 and 20000 with specific serial numbers listed in the notice.
Check your system's model number and serial numbers against the list provided in the recall notice.
The recall notice does not specify a remedy, so contact ViewRay, Inc. for further instructions.
We’ve drafted a message you can send ViewRay to request your refund or repair — edit it as you like.
Subject: Recall Z-1803-2020 — ViewRay ViewRay Hello, I own a ViewRay that is covered by recall Z-1803-2020 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.
