FDA DevicesClass II
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/R...
Published: January 28, 2026Recall ID: Z-1102-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
Affected Products
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
Additional Source Details
| Field | Value |
|---|---|
| City | Stockholm |
| Event id | 98117 |
| Address 1 | Eugeniavagen 18c |
| Code info | UDI: 0735000201031020201216. GTIN: 07350002010310. Serial Numbers: 10.1.0.613. Software Revision: RayStation 10B. Expiration Date: 2027-02-01. |
| Postal code | N/A |
| Report date | 20260128 |
| Product type | Devices |
| Product quantity | 0 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251128 |
| Initial firm notification | |
| Center classification date | 20260116 |
Overview
- Recalling FirmRAYSEARCH LABORATORIES AB
- StatusOngoing
- Risk LevelClass II
- DistributionRefer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS