RaySearch recalls specific versions of RayStation and RayPlan software due to potential incorrect treatment plan reports, which could affect radiation therapy accuracy. Affected users should check their software versions.
Two issues were found with the treatment plan report: 1) There may be incorrect information for the percent of a region of interest with a clinical goal that is outside the dose grid; and 2) For RayStation and RayPlan 9B and 10A, 6D couch angles may be incorrect.
RaySearch Laboratories is recalling specific versions of RayStation and RayPlan software because they may contain errors in treatment plan reports. These errors could lead to incorrect radiation dosing during cancer treatment, potentially affecting patient safety.
The software may report incorrect percentages of a region of interest that fall outside the dose grid, and for certain versions, couch angles may be inaccurate. These errors could lead to improper radiation targeting during cancer treatment.
Users of RaySearch RayStation and RayPlan software versions listed in the recall are affected. Medical professionals using these software tools for radiation therapy planning are most at risk.
Check if your software version matches the listed versions (e.g., RayStation 4.0, 4.5, 4.7, 4.9, 5.0, etc.) or the specific software version numbers provided in the recall. The recall includes all service packs for these versions.
Review your RayStation or RayPlan software version to see if it matches the affected versions listed in the recall.
Yes, RayStation 10A and RayPlan 10A are affected, but only the base software, not the 10A service pack.
The software may report incorrect percentages of a region of interest outside the dose grid, and for RayStation and RayPlan 9B and 10A, couch angles may be inaccurate.
No action is needed if your software version is not listed in the recall.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-0589-2021 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-0589-2021 from RaySearch. 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.
