RaySearch recalls specific versions of RayStation and RayPlan software due to potential dose labeling errors when merging clinical beams. Affected versions include 4.5 to 10.1 with certain service packs. No immediate action is required but users should check their software version.
For some LINAC types, merging clinical beams with beams of approximate dose may lead to the approximate dose erroneously labeled as clinical dose. Merge beams can be used manually, in scripting, or as part of the Automated breast planning feature. In some cases, when merging two beams where the first beam has clinical dose and the second beam has approximate dose, the dose of the resulting beam will be labeled as Clinical, although dose for some of the beam segments is still calculated with the SVD dose engine and it should be labeled Approximate: Mixed dose. The difference between approximate and final Clinical dose is in most cases small, but there can be body sites such as lung where the difference can be significant.
RaySearch Laboratories is recalling specific versions of their RayStation and RayPlan software due to a potential error in dose labeling when merging certain radiation therapy beams. This could lead to incorrect dose calculations for some patients, particularly in areas like the lungs where the difference might be significant. The recall does not require immediate action but users should verify their software version.
When merging beams in radiation therapy planning, the software may incorrectly label the dose as 'Clinical' when it should be 'Approximate: Mixed dose'. This error is most concerning for body areas like the lungs where the dose difference could be significant, though the impact is typically small in most cases.
Users of RaySearch RayStation and RayPlan software versions 4.5 to 10.1 with specific service packs are affected. Patients receiving radiation therapy using these versions are most at risk due to potential inaccuracies in dose calculations for certain body areas.
Check if your software version matches the listed versions (4.5 to 10.1) with specific service packs. The software includes build numbers like 4.5.1.14 or UDI codes such as 07350002010020.
Verify your RayStation or RayPlan version against the list of affected versions provided in the recall notice.
No, the recall does not require immediate action. Users should check their software version to see if they are affected.
The software may incorrectly label dose as 'Clinical' when it should be 'Approximate: Mixed dose', which could lead to inaccurate dose calculations for some patients, particularly in areas like the lungs.
Check your software version against the list of affected versions (4.5 to 10.1) with specific service packs and build numbers provided in the recall notice.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1597-2021 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1597-2021 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.
