TomoHelical and TomoDirect plans in RayStation 6 — Class II medical device recall Z-0848-2022
Terminated recall by RAYSEARCH LABORATORIES AB, reported 2022-04-06, distributed nationwide. If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the
| Recall number | Z-0848-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2021-09-09 |
| Classified | 2022-03-31 |
| Reported by FDA | 2022-04-06 |
| Terminated | 2024-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 51 |
| UPC / GTIN / UDI-DI | 07350002010037, 07350002010068, 07350002010075, 07350002010082, 07350002010112, 07350002010129, 07350002010136, 07350002010174, 07350002010204, 07350002010235, 07350002010242, 07350002010266, 07350002010297, 07350002010303, 07350002010310, 07350002010365, 07350002010389, 07350002010433 |
Product
TomoHelical and TomoDirect plans in RayStation 6, 7, 8A, 8B, 9A, 9B, 10A, 10B and 11A. Build Numbers: 6.1.1.2, 6.2.0.7, 6.3.0.6, 7.0.0.19, 8.0.0.61, 8.0.1.10, 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113, 9.1.0.933, 9.2.0.483, 10.0.0.1154, 10.0.1.52, 10.1.0.613, 11.0.0.951 or 11.0.1.29.
Reason for recall
If the dynamic jaw mode is used and an optimization is continued after changing the dose grid or modifying the target ROI, the positions of the jaws may change unexpectedly for some control points. User must be aware to avoid unnecessary jaw openings during treatment planning
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-0848-2022. 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.