RaySearch recalls software versions 4-11A with specific build numbers due to potential under/overestimation of radiation density in treatment planning. Affected users should check their version and contact RaySearch for updates.
An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated
RaySearch Laboratories is recalling specific versions of their radiation treatment planning software (RayStation and RayPlan) from versions 4 to 11A. The issue could lead to incorrect radiation dose calculations in treatment planning, potentially affecting patient safety. Users should check their software version and contact RaySearch for guidance.
The software may incorrectly calculate radiation density in specific areas of the treatment plan, potentially leading to under- or overestimation of the dose delivered to the patient. This could affect the accuracy of radiation therapy treatments.
Users of RayStation or RayPlan software versions 4 through 11A with the listed build numbers. Medical professionals using these software versions for radiation treatment planning are most at risk.
Check your software version and build number. Affected versions include RayStation 4.0.0.14 through RayPlan 11.0.1.29 with specific build numbers listed in the recall notice.
Identify your RayStation or RayPlan version and build number to determine if it is affected by this recall.
Check your software version and build number against the list provided in the recall notice to see if it is affected.
Contact RaySearch Laboratories directly for guidance on next steps, as the recall does not include a specific remedy.
The recall does not specify a remedy or fix; users should contact RaySearch for updates.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-0849-2022 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-0849-2022 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.
