RayStation 9 — Class II medical device recall Z-1744-2024
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2024-05-08, distributed nationwide. Potential for reported SSD to be too high.
| Recall number | Z-1744-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, Sweden |
| Recall initiated | 2024-03-28 |
| Classified | 2024-05-01 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CN, CO, CY, CZ, DE, DK, DZ, EE, EG, ES, FR, GB, HU, ID, IL, IN, IR, IT, JP, KR, MA, MY, NL, NO, NZ, PL, QA, SE, SG, SI, TH, TR, TW, ZA |
| Quantity | 63 units |
| UPC / GTIN / UDI-DI | 07350002010174, 07350002010488 |
| Serial numbers | 9.0.0.113, 9.0.1.142 |
| Expiration dates | 2027-12-15 |
Product
RayStation 9.0.0.113 and 9.0.1.142. Radiation Therapy Treatment Planning System.
Reason for recall
Potential for reported SSD to be too high.
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-1744-2024. 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.