RayStation/RayPlan versions 4 — Class II medical device recall Z-0849-2022
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2022-04-06, distributed nationwide. An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partia
| Recall number | Z-0849-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2021-09-22 |
| Classified | 2022-03-31 |
| Reported by FDA | 2022-04-06 |
| Distributed | Nationwide (US) |
| Quantity | 478 licenses |
| UPC / GTIN / UDI-DI | 07350002010013, 07350002010020, 07350002010068, 07350002010075, 07350002010082, 07350002010112, 07350002010129, 07350002010136, 07350002010174, 07350002010204, 07350002010235, 07350002010242, 07350002010266, 07350002010297, 07350002010303, 07350002010310, 07350002010365, 07350002010389, 07350002010433 |
Product
RayStation/RayPlan versions 4 - 11A, including service packs. Build Stations: 4.0.0.14, 4.0.3.4, 4.3.0.14, 4.5.1.14, 4.7.2.5, 4.7.3.13, 4.7.4.4, 4.7.5.4, 4.7.6.7, 4.9.0.42, 5.0.1.11, 5.0.2.35, 5.0.3.17, 6.0.0.24, 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
An issue where the combined density in a dose grid voxel partially covered by the External ROI and also partially covered by an ROI of type Bolus, Support or Fixation may be unexpected.The density in the voxel can be both under- and overestimated
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-0849-2022. 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.