Brand Name: RayStation- Intended as a Radiation Therapy Treatment… — Class II medical device recall Z-1191-2025
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2025-02-26, distributed nationwide. Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evalua
| Recall number | Z-1191-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2025-01-16 |
| Classified | 2025-02-19 |
| Reported by FDA | 2025-02-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CN, DE, DK, ES, FR, GB, HK, IN, IT, JP, KR, NL, NO, PL, SG, TH, TW |
| Quantity | 32 |
| UPC / GTIN / UDI-DI | 07350002010549, 07350002010556, 07350002010679, 07350002010730 |
| Lot numbers | 0735000201054920220616, 0735000201055620230630, 0735000201067920221007, 0735000201073020230913 |
| Serial numbers | 13.0.0.1547, 13.1.0.144, 14.0.0.3338 |
| Model numbers | 13.0.0.1547, 13.1.0.144, 14.0.0.3338 |
| Expiration dates | 2028-07-07 |
Product
Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 and 14.0.0.3338 Software Version: RayStation 12A, 12A Service Pack 1 and 2 and 2023B
Reason for recall
Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.
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-1191-2025. 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.