Recall archive / FDA device enforcement
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version... — FDA record Z-1106-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Nov 28, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 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
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Quantity
- 119
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1106-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot Code: UDI: 0735000201055620230630, 0735000201072320231213, 0735000201088420250129 GTIN: 07350002010556, 07350002010723, 07350002010884 Serial Numbers: 14.0.0.3338, 15.0.0.430, 15.1.3.10 Software Revisions: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Expiration Date: 2030-02-21 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Jan 28, 2026
- Recall initiation date
- Nov 28, 2025
- Center classification date
- Jan 16, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.