RaySearch Laboratories AB recalled its RayStation/RayPlan system on November 28, 2025. The recall affects software version RayStation 10B SP1, citing a high-risk hazard in radiation dose calculations. Affected systems may not invalidate doses as intended for certain Regions of Interest.
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 system is a radiation therapy planning tool used by healthcare providers to calculate radiation doses for cancer treatment. It is utilized in clinical settings for its precision in treatment planning.
The hazard arises when certain Regions of Interest lack contours or have material overrides, leading to incorrect dose calculations. This can result in inadequate or excessive radiation exposure to patients.
This recall is not part of a broader industry pattern.
Patients relying on this system may face delays in treatment or potential health risks due to improper dosing, thus emphasizing the urgency of addressing the recall.
Look for the model number and software version in the system settings or documentation provided with the device.
Expect a processing timeline of approximately 4-6 weeks for refunds or replacements.
Keep records of your communication with the manufacturer and any relevant documents regarding the device.
The recall involves the RayStation/RayPlan system, model number 10.1.1, software version RayStation 10B SP1. The product is used for radiation therapy treatment planning. Specific lot code for reference: UDI: 0735000201047120220131.
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