RaySearch Laboratories recalls RayStation/RayPlan 8A software build 8.0.0.61 due to potential incorrect table position propagation during pitch/roll corrections. Affected users should contact for remedy.
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 RayStation/RayPlan 8A software version 8.0.0.61. This version may incorrectly propagate table positions when applying pitch or roll corrections, which could lead to inaccurate treatment planning in radiation therapy.
The software may incorrectly calculate table positions when pitch or roll corrections are applied. 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 errors in radiation therapy treatment planning.
Radiation therapy professionals using RayStation/RayPlan 8A software version 8.0.0.61 for treatment planning. Those most at risk are clinicians who rely on precise table positioning for patient treatments.
Check for the software version number 8.0.0.61 on the RayStation/RayPlan system. The unique device identifier (UDI) 07350002010112 is also associated with this recall.
Reach out to RaySearch Laboratories for guidance on the recall and next steps.
The recall indicates a potential for incorrect table position propagation during pitch/roll corrections, but the software is not considered immediately dangerous. Users should contact RaySearch Laboratories for specific guidance.
Contact RaySearch Laboratories directly for instructions on the recall and remedy options.
Check for the software version 8.0.0.61 and the unique device identifier (UDI) 07350002010112.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1462-2020 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1462-2020 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.
