RaySearch Laboratories recalls RayStation software versions 6 through 11A with specific build numbers due to potential unexpected jaw position changes during radiation treatment planning if dose grid or target ROI is modified after optimization.
If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning
RaySearch Laboratories is recalling specific versions of their RayStation software (6 through 11A) because changing the dose grid or target area during treatment planning after using dynamic jaw mode could cause unexpected jaw movements. This could lead to unintended radiation exposure if not corrected.
If a user changes the dose grid or modifies the target radiation area after completing an optimization process in dynamic jaw mode, the software may unexpectedly adjust jaw positions for some treatment points. This could cause unintended radiation exposure to healthy tissue if not corrected during planning.
Medical professionals using RaySearch RayStation software for radiation treatment planning are affected. Those who have the specific build numbers listed in the recall are most at risk.
Check if you have RayStation software versions 6 through 11A with build numbers including 6.1.1.2, 6.2.0.7, or other specific build numbers listed in the recall. The software was sold with the UDI-DI codes provided in the recall notice.
Verify your RayStation software version and build number against the list of affected versions provided in the recall notice.
Ensure that you do not change the dose grid or modify the target radiation area after completing an optimization process in dynamic jaw mode.
RayStation software versions 6 through 11A with specific build numbers including 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, and 11.0.0.951 or 11.0.1.29.
Check your software version and build number against the list provided in the recall. Do not change the dose grid or modify the target radiation area after completing an optimization process in dynamic jaw mode.
The recall does not specify a fix or remedy. Users must follow the treatment planning process carefully to avoid the hazard.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-0848-2022 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-0848-2022 from RaySearch Laboratories. 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.
