RaySearch recalls software versions 8B through 2024A due to risk of incorrect silicone implant material selection in treatment planning.
A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
RaySearch Laboratories is recalling specific versions of their RayStation software because a use error could cause incorrect selection of silicone implant material during treatment planning. This could lead to improper treatment of patients with silicone gel polymer implants.
The software may incorrectly select 'Silicon' (Si) instead of 'Silicone' when processing implant materials. This error could lead to improper radiation treatment planning for patients with silicone gel polymer implants, potentially causing ineffective or harmful radiation delivery.
Users of RayStation software versions 8B through 2024A, particularly medical professionals performing radiation therapy treatments involving silicone gel polymer implants. Patients receiving such treatments are at risk if the software misidentifies implant material.
Check your RayStation software version numbers (e.g., 8B, 9A, 10A) in the software's version history or help menu. The affected versions include specific build numbers listed in the recall notice.
Review your RayStation software version number to confirm if it is among the recalled versions (8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A).
RayStation versions 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, and 2024A, including specific service packs, are affected.
The software may incorrectly select 'Silicon' (Si) instead of 'Silicone' for silicone gel polymer implants during treatment planning, which could lead to improper radiation therapy.
Yes, you should check your software version to see if it is affected. If it is, you may need to update to a newer version or contact RaySearch for guidance.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1482-2024 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1482-2024 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.
