RaySearch recalls specific versions of RayStation software for radiation therapy planning due to potential overdose risk if beam models are asymmetric. Users must verify their version and contact RaySearch for updates.
If the beam model has a highly asymmetric primary source, it is not correctly taken into account in the calculation of DMLC fields when the collimator is rotated. This could lead to potentially significant overdosage at delivery. The user must be aware of the issue to avoid incorrect dose calculations during treatment planning.
RaySearch recalls several versions of its RayStation software for radiation therapy treatment planning. If the software incorrectly calculates dose distributions when the collimator rotates, it could lead to overdosing patients during treatment. This is serious but requires user awareness to prevent incorrect dose calculations.
The software may not properly account for asymmetric beam sources when the collimator rotates during treatment planning. This could cause significant overdosage to patients during radiation therapy delivery. Users must manually check for this issue to avoid incorrect dose calculations.
Clinically trained radiation therapy staff using RaySearch RayStation software versions 4.5 through 8A are most at risk. Patients receiving treatment with these versions may be affected if incorrect dose calculations occur.
Check if your RayStation software version is listed in the specific versions mentioned: 4.5, 4.7, 4.9 (RayPlan 1), 5, 6 (RayPlan 2), 7 (RayPlan 7), or 8A (RayPlan 8A). The software is used by radiation therapy professionals for treatment planning.
Identify your RayStation version by checking the software's version number in the system settings or documentation.
Reach out to RaySearch directly for guidance on whether your version requires correction or updates.
The recall affects the software used by radiation therapy staff. Patients are not directly affected unless incorrect dose calculations occur due to the software issue.
Check if your RayStation version is listed in the specific versions: 4.5, 4.7, 4.9 (RayPlan 1), 5, 6 (RayPlan 2), 7 (RayPlan 7), or 8A (RayPlan 8A).
No, but users must be aware of the issue to avoid incorrect dose calculations. The recall does not require immediate discontinuation.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-2497-2018 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-2497-2018 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.
