RaySearch Laboratories recalls software version 8.0.1.10 for potential incorrect table position calculations during treatment planning. Affected users should contact the manufacturer for updates.
There is a potential for erroneous propagation of the current tabletop positions when applying pitch or roll correction. Even though pitch and roll correction is never propagated, non-zero pitch or roll causes the lateral, longitudinal and vertical values propagated to be incorrect.
RaySearch Laboratories is recalling a specific software update for their radiation treatment planning system. This update could cause incorrect positioning calculations during treatment, potentially affecting patient safety.
The software may incorrectly calculate table positions when applying pitch or roll corrections. Even though pitch and roll corrections themselves aren't propagated, non-zero angles cause lateral, longitudinal, and vertical values to be inaccurate. This could lead to improper patient positioning during radiation therapy.
Medical professionals using RayStation or RayPlan software for radiation treatment planning systems. Those with the specific software version 8A Service Pack 1, Build 8.0.1.10 are most at risk.
Check if you have RayStation or RayPlan software version 8A Service Pack 1 with build number 8.0.1.10. The unique device identifier (UDI) 07350002010136 is associated with this version.
Reach out to RaySearch Laboratories for guidance on the specific software update needed.
The recall indicates a potential for incorrect table position calculations, which could affect treatment accuracy. However, the hazard level is low risk as the software does not cause immediate harm in normal use.
Check for RayStation or RayPlan software version 8A Service Pack 1 with build number 8.0.1.10. The unique device identifier (UDI) 07350002010136 is associated with this version.
Contact RaySearch Laboratories for guidance on the specific software update needed to resolve the issue.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1463-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1463-2020 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.
