RayStation Model Number: — Class II medical device recall Z-1427-2021
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2021-04-21, distributed nationwide. Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
| Recall number | Z-1427-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2021-03-25 |
| Classified | 2021-04-15 |
| Reported by FDA | 2021-04-21 |
| Distributed | Nationwide (US) |
| Quantity | 1 systems |
Product
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
Reason for recall
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
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-1427-2021. 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.