RAYSEARCH LABORATORIES AB recalls Brand Name: RayStation Product Name: RayStation/RayPlan
- Recalling company
- RAYSEARCH LABORATORIES AB
- Product
- Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 28, 2025
- Reported
- Jan 28, 2026
- Distribution
- Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
- Status
- Ongoing
- Quantity
- 8
- Lot / codes
- Lot Code: UDI: 0735000201054920220616, 0735000201067920221007, 0735000201073020230913 GTIN: 07350002010549, 07350002010679, 07350002010730 Serial Numbers: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Revisions: RayStation 12A, 12A SP 1, 12A SP2 Expiration Date: 2028-07-07
- Company location
- Stockholm
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1105-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1105-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.