RaySearch Laboratories AB recalled 22 units of its radiation therapy treatment planning system on November 28, 2025. The recall affects software versions RayStation 11B and its updates due to a high hazard risk. The software may not invalidate calculated radiation doses correctly under certain conditions, potentially impacting patient safety.
Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact RAYSEARCH LABORATORIES AB or your healthcare provider for instructions. Notification method: E-Mail
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The RayStation/RayPlan software is used for planning radiation therapy treatments for patients with cancer. Healthcare providers rely on accurate dose calculations for effective treatment.
The software issue may prevent correct invalidation of radiation doses, especially for certain ROIs without contours. This can lead to serious treatment planning errors.
This recall is not part of a broader industry pattern.
The recall necessitates immediate cessation of use to prevent potential harm to patients, affecting ongoing treatment plans and requiring urgent resolution.
Serial numbers and model numbers can typically be located in the software settings or installation documentation.
Expect a timeline of 4-8 weeks for refunds or replacements after contacting RaySearch Laboratories.
Keep records of all communications regarding the recall, including emails and notes from phone calls.
Affected model numbers include 12.0.0, 12.1.0, 12.0.3, 12.0.4, and 12.3.0. The software versions include RayStation 11B, 11B SP1, 11B SP2, 11B SP3, and 11B SPT1.
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