RayStation 11B — Class II medical device recall Z-1299-2022
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2022-07-06, distributed nationwide. This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B
| Recall number | Z-1299-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, Sweden |
| Recall initiated | 2022-06-10 |
| Classified | 2022-06-28 |
| Reported by FDA | 2022-07-06 |
| Terminated | 2024-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 26 |
Product
RayStation 11B
Reason for recall
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
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-1299-2022. 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.