RaySearch Laboratories recalls specific RayStation software versions due to incorrect isocenter shifts in dose tracking calculations, which could affect radiation therapy accuracy.
Isocenter shifts when using dose tracking in RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayStation 7 and RayStation 8A. In these versions, isocenter shifts in dose tracking are incorrectly interpreted according to the DICOM patient coordinate system.
RaySearch Laboratories is recalling several versions of their RayStation software (3.5 through 8.0) because dose tracking calculations can shift the treatment target incorrectly. This could lead to inaccurate radiation therapy delivery if the software is used without the fix.
In these software versions, the system incorrectly calculates where the treatment target should be positioned during radiation therapy. This is due to a flaw in how the software interprets the patient's coordinate system when tracking radiation doses.
Users of radiation therapy systems that rely on RayStation software versions 3.5 through 8.0 are affected. Medical professionals using these versions for cancer treatment are most at risk.
Check if your RayStation software version matches the listed numbers: 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, 4.0.3.4, 4.5.0.19, 4.5.1.14, 4.5.2.7, 4.7.0.15, 4.7.1.10, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 5.0.0.37, 5.0.1.11, 5.0.2.35, 6.0.0.24, 6.1.0.26, 6.1.1.2, 6.2.0.7, 7.0.0.19, 8.0.0.61, or 8.0.1.10.
Identify your RayStation software version by checking the version numbers listed in the recall notice.
The recall notice does not specify a deadline for updating software, but the manufacturer recommends checking for the fix.
The software may incorrectly calculate treatment target positions during radiation therapy, potentially affecting treatment accuracy.
The recall notice does not mention a specific remedy or update process.
We’ve drafted a message you can send RaySearch Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-0679-2019 — RaySearch Laboratories RaySearch Laboratories Hello, I own a RaySearch Laboratories that is covered by recall Z-0679-2019 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.
