Raysearch recalls Raystation radiation therapy software versions 9.0.0-13.1.0 with incorrect collimator angle in exported DICOM plans. Users may need to update software to prevent treatment errors.
It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.
Raysearch is recalling its Raystation radiation therapy software versions 9.0.0 through 13.1.0 because setting a non-zero collimator angle in the Virtual Simulation module can cause incorrect angles in exported treatment plans. This could lead to improper radiation delivery during therapy if not corrected.
When a non-zero collimator angle is set in the Virtual Simulation module, the software shows the correct angle in the interface but exports it as zero in the DICOM treatment plan. This means the actual radiation delivery might not match the intended plan, potentially causing treatment errors.
Radiation therapy professionals using Raysearch Raystation software versions 9.0.0 through 13.1.0 are affected. Those creating treatment plans with the Virtual Simulation module are most at risk of incorrect radiation delivery.
Check if your Raystation software version is listed in the model numbers 9.0.0 through 13.1.0 or software versions 9A through 12B. The recall includes specific UDI-DI numbers starting with 0735000201067920221007.
Verify your Raystation version by checking the software version number in the program interface or documentation.
Install the latest software update from Raysearch to fix the collimator angle issue in exported plans.
The recall occurs because setting a non-zero collimator angle in the Virtual Simulation module can cause the exported treatment plan to show a zero angle, potentially leading to incorrect radiation delivery.
No, you can continue using the software but you must update to the latest version to fix the issue.
Software versions 9.0.0 through 13.1.0 and software versions 9A through 12B, including service packs.
We’ve drafted a message you can send Raysearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1281-2023 — Raysearch Raysearch Hello, I own a Raysearch that is covered by recall Z-1281-2023 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.
