RaySearch recalls software versions 4.0 to 5 Service Pack 2 for radiation therapy. A software error may cause underestimation of radiation dose, potentially affecting treatment safety.
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RaySearch Laboratories recalls specific versions of its RayStation software for radiation therapy and medical oncology. A software error could lead to underestimating the radiation dose delivered to patients, which might affect treatment safety.
The software error in dose calculation algorithms could result in underestimating the radiation dose delivered to patients. This might lead to insufficient radiation being administered during treatment, potentially affecting the effectiveness of therapy.
Healthcare professionals using RaySearch RayStation software for radiation therapy or medical oncology treatments. Patients receiving these treatments are at risk if the software error affects dose calculation.
Check if you have RayStation software versions 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, or 5.0.1.11, 5.0.2.35. These versions were sold for radiation therapy and medical oncology use.
Identify your RayStation version by checking the build numbers listed in the recall notice.
The recall states a software error could result in underestimating radiation dose, which might affect treatment safety. However, the specific risk level is not described as causing serious injury in normal use.
Affected versions include 4.0.3.4, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 5.0.1.11, and 5.0.2.35.
The recall does not specify a stop-use instruction or deadline. Users should check their version and consider updating if they are affected.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-2339-2020 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-2339-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
