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 11A SP2, RayStation 11A SP3. Radi

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.

Details from the source

Reason for recall: 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. Distribution: Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS Quantity: 10 units Lot/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.

UPC codes

07350002010389, 07350002010433, 07350002010440, 07350002010631

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.