Z-1108-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 28, 2026
- Initiation Date
- November 28, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 0
Product Description
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
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 Pattern
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
Code Information
UDI: 0735000201076120240508, 0735000201080820241217 GTIN: 07350002010761, 07350002010808 Serial Numbers: 15.1.0.852, 15.2.0.107 Software Revision: RayStation 2024A SP1, RayStation 2024A SP2 Expiration Date: 2030-04-15