RaySearch America recalls RayStation 4-11B and RayPlan 1-8A software versions due to potential dose errors in radiation treatment planning. Affected users should contact RaySearch for details.
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
RaySearch America is recalling specific versions of its RayStation and RayPlan software used in radiation treatment planning. The software may calculate incorrect radiation doses to patients, which could lead to improper treatment.
The software may miscalculate the distance between the radiation source and the patient's skin or surface, leading to incorrect radiation doses. This could result in under- or over-treatment of patients during radiation therapy.
Medical professionals using RaySearch software for radiation treatment planning. Patients receiving treatment with affected software versions are at risk of incorrect radiation dosing.
Check if your software version is listed in the recall details: RayStation 4.0 (4.0.0.14) to RayStation 5, or RayPlan 1, 2, 7-11B with specific service packs. Also check the UDI numbers provided in the recall.
Reach out to RaySearch America for specific instructions on how to verify your software version and receive a remedy.
RayStation 4.0 (4.0.0.14) to RayStation 5, RayPlan 1, 2, 7-11B with specific service packs, and software versions listed in the recall details.
Check your software version against the list of affected versions provided in the recall notice, or verify your Unique Device Identifier (UDI) number.
Contact RaySearch America directly for instructions on verifying your software and receiving the necessary remedy.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-0850-2022 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-0850-2022 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.
