RaySearch Laboratories recalls specific RayStation software versions due to potential dose calculation errors in radiation therapy planning. Affected versions include 3.5 through 6.2.
When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong
RaySearch Laboratories is recalling several versions of their RayStation and RayPlan software used in radiation therapy planning. The software may calculate radiation doses incorrectly when using very large numbers of simulation histories, which could lead to unsafe treatment plans.
The software may produce incorrect radiation dose calculations when processing a very large number of simulation histories. This could result in treatment plans that deliver unsafe radiation doses to patients.
Healthcare professionals using RayStation software for radiation therapy planning are affected. Patients receiving treatment with these versions may be at risk of inaccurate radiation dosing.
Check if you own RayStation software versions 3.5.0.16 through 6.2.0.7 as listed in the recall notice. The software is used for radiation therapy treatment planning in medical facilities.
Identify your RayStation software version by checking the version numbers listed in the recall notice.
The recall indicates a potential for incorrect dose calculations in specific scenarios, but the risk is low and does not require immediate action for most users.
Check your software version against the list of affected versions provided in the recall notice, which includes versions from 3.5.0.16 through 6.2.0.7.
No immediate action is required. The recall does not specify a need to stop using the software, only to check the version and be aware of potential calculation errors.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1930-2019 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-1930-2019 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.
