RaySearch Laboratories recalls RayStation versions 9A-11A with incorrect beam delivery positions. Affected software versions may cause treatment errors if used without correction.
Initial delivery positions will be set incorrectly when having setup beam(s) at the localization point.
RaySearch Laboratories is recalling several versions of their radiation treatment planning software (RayStation 9A, 9B, 9B SP1, 10A, 10A SP1, 10B, 11A) because initial beam setup positions can be incorrect. This could lead to improper radiation treatment delivery if the software is used without correction.
The software may set radiation beam positions incorrectly during initial setup at the localization point. This could result in improper radiation delivery to patients during treatment. The hazard is specific to the software's configuration process and not a general safety issue.
Healthcare providers using RayStation software for radiation treatment planning are most at risk. Patients receiving treatment with affected versions may experience incorrect radiation delivery.
Check if your software version matches the listed build numbers: RayStation 9.0 (9.0.0.113), 9.1 (9.1.0.933), 9.1 SP1 (9.2.0.483), 10.0 (10.0.0.1154), 10.0 SP1 (10.0.1.52), 10.1 (10.1.0.613), or 11.0 (11.0.0.951).
Verify your RayStation version against the listed build numbers to confirm if it is affected.
The recall addresses potential incorrect beam setup during treatment planning, which could affect radiation delivery. However, the hazard is specific to the software configuration process and not a general safety issue.
Check if your RayStation version matches the listed build numbers: 9.0 (9.0.0.113), 9.1 (9.1.0.933), 9.1 SP1 (9.2.0.483), 10.0 (10.0.0.1154), 10.0 SP1 (10.0.1.52), 10.1 (10.1.0.613), or 11.0 (11.0.0.951).
The recall does not specify a remedy, so affected users should check their software version and contact RaySearch Laboratories for guidance.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2138-2021 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-2138-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
