RAYSEARCH LABORATORIES AB: RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- RAYSEARCH LABORATORIES AB
- Product
- RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
- Recall initiated
- 2025-11-28
- Code info
- Lot Code: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916, 35000201063120220616. GTIN: 07350002010389, 07350002010433, 07350002010440, 07350002010631. Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116, 11.0.4.15. Software Revision: RayStation 11A, 11A SP1, 11A SP2, 11A SP3. Expiration Date: 2027-06-22.
- Product quantity
- 10 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Stockholm
- Country
- Sweden
- Event id
- 98117
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