RayStation/RayPlan — Class II medical device recall Z-1102-2026
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2026-01-28. Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of
| Recall number | Z-1102-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, Sweden |
| Recall initiated | 2025-11-28 |
| Classified | 2026-01-16 |
| Reported by FDA | 2026-01-28 |
| Quantity | 0 |
| UPC / GTIN / UDI-DI | 07350002010310 |
| Serial numbers | 10.1.0.613 |
| Model numbers | 10.1 |
| Expiration dates | 2027-02-01 |
Product
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1102-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.