RaySearch recalls software versions 4.0-9.0 for possible incorrect radiation dose calculations during cancer treatment planning. Users should verify their version and contact RaySearch for guidance.
Three issues found: i) The Map ROI options in the ROI list in the Structure Definition module may generate unintended ROI geometries ii) Elekta guard leaf behavior. There is an interoperability issue with Elekta regarding setting of guard leaves. iii)SSD, when intended as source-to-surface distance, it sometimes gives source-to-skin distance.To the best of our knowledge, these issues have not caused any patient mistreatment or other incidents. However, the user must be aware of the following information to avoid incorrect dose calculations during treatment planning.
RaySearch Laboratories is recalling several versions of their RayStation software used in cancer treatment planning. These versions may generate incorrect radiation dose calculations if certain features are used, but no patient harm has been reported.
Three issues in the software could lead to incorrect radiation dose calculations: unintended ROI geometries, interoperability problems with Elekta guard leaves, and source-to-surface distance being misinterpreted as source-to-skin distance. However, no patient harm has been reported.
Healthcare professionals using RaySearch RayStation software for radiation treatment planning. Those with specific software versions listed in the recall are most at risk.
Check your RayStation software version number. Affected versions include 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, and 9.0 with specific build numbers listed in the recall.
Verify your RayStation software version against the list of affected versions provided in the recall.
No patient harm has been reported as of the recall announcement.
Affected versions include 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, 6.3, 7.0, 8.0, 8.1, and 9.0 with specific build numbers listed in the recall.
No immediate action is required; users should check their version and contact RaySearch for guidance.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-0866-2020 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-0866-2020 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.
