RaySearch recalls specific versions of RayStation radiation therapy software due to potential incorrect dose calculations in large or off-axis radiation fields, requiring validation with Beam 3D Modeling.
The firm has learned that some RayStation/RayPlan users have commissioned machines with erroneous Beam profile correction parameters. These parameters affect the dose calculated in corners of large or off-axis fields. This effect cannot be seen in the Beam Commissioning module and dose in large or off-axis fields needs to be validated using the Beam 3D Modeling module in RayPhysics/RayPlan Physics. The user must be aware to avoid incorrect dose calculations during treatment planning.
RaySearch is recalling specific versions of its RayStation radiation therapy software because some users have experienced incorrect dose calculations in large or off-axis radiation fields. This could lead to improper treatment planning if not corrected using the Beam 3D Modeling module.
The software contains erroneous beam profile correction parameters that affect dose calculations in corners of large or off-axis radiation fields. These errors cannot be detected in the Beam Commissioning module and require validation using the Beam 3D Modeling module to ensure accurate treatment planning.
Clinically trained radiation therapy staff who use RayStation software versions 2.5 through 7.0 are most at risk. The recall affects users who have commissioned radiation machines with the specified software versions.
Check if your RayStation software version is listed among 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, or 7.0. The software is used for radiation therapy treatment planning by trained medical professionals.
Identify your RayStation version by checking the software's version number in the system settings.
Use the Beam 3D Modeling module in RayPhysics/RayPlan Physics to verify dose calculations in large or off-axis fields.
RaySearch has learned that some users have commissioned radiation machines with erroneous beam profile correction parameters that affect dose calculations in large or off-axis fields.
Your software is affected if it is version 2.5, 3.5, 4.0, 4.3, 4.5, 4.7, 4.9, 5.0, 6.0, 6.1, 6.2, or 7.0.
No, but you must validate dose calculations in large or off-axis fields using the Beam 3D Modeling module to ensure accurate treatment planning.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-2554-2018 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-2554-2018 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.
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.
