RaySearch Laboratories recalls RayStation software versions 4.0-9.1 due to potential inaccuracies in radiation treatment planning that could lead to uneven dose distribution in complex treatments.
Due to physical limitations of the treatment machine, the maximum field opening for Siemens Virtual Wedge fields recommended by the LINAC vendor will be more restricted in the wedged direction than the maximum field opening without a wedge. Delivering a larger field opening with a virtual wedge will not result in a wedged field shape over the entire field. Instead, a high dose plateau region will be the result at the toe side of the field beyond the recommended field size.
RaySearch Laboratories is recalling several versions of their RayStation radiation treatment planning software. Using these versions with certain Siemens linear accelerators may cause uneven radiation doses in treatment areas, potentially affecting treatment accuracy.
The software's physical limitations cause the maximum radiation field size to be restricted when using virtual wedges. This results in uneven dose distribution, creating a high-dose area at the edge of the treatment field rather than a uniform dose across the entire area.
Medical professionals using RayStation software for radiation therapy planning with Siemens linear accelerators are most at risk. Patients receiving treatment with these specific software versions could experience inaccurate radiation delivery.
Check if you have RayStation software versions 4.0, 4.5, 4.7, 4.9, 5.0, 6.0, 7.0, 8.0, 8.1, 9.0, or 9.1. The software is used for radiation therapy planning with Siemens linear accelerators.
Identify your RayStation software version by checking the version numbers listed in the recall notice.
The recall indicates a potential risk of uneven radiation dose distribution in specific treatment scenarios, but the software is not considered immediately dangerous for normal use.
No, the recall does not require immediate discontinuation of use. The software can continue to be used with proper configuration and monitoring.
Check your software version and contact RaySearch Laboratories for guidance on whether your version requires action.
We’ve drafted a message you can send RaySearch to request your refund or repair — edit it as you like.
Subject: Recall Z-1598-2020 — RaySearch RaySearch Hello, I own a RaySearch that is covered by recall Z-1598-2020 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.
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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.
