RayStation 4-11B — Class II medical device recall Z-0850-2022
Ongoing recall by RaySearch America Inc, reported 2022-04-06, distributed nationwide. Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation
| Recall number | Z-0850-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RaySearch America Inc, New York, NY, United States |
| Recall initiated | 2022-02-11 |
| Classified | 2022-03-31 |
| Reported by FDA | 2022-04-06 |
| Distributed | Nationwide (US) |
| UPC / GTIN / UDI-DI | 07350002010013, 07350002010020, 07350002010068, 07350002010075, 07350002010082, 07350002010112, 07350002010129, 07350002010136, 07350002010174, 07350002010204, 07350002010235, 07350002010242, 07350002010266, 07350002010297, 07350002010303, 07350002010310, 07350002010365, 07350002010389, 07350002010426, 07350002010433, 07350002010440, 07350002010471 |
Product
RayStation 4-11B, and RayPlan 1, 2, 7-11B including some service packs: RayStation 4.0 (4.0.0.14) to RayStation 5 Service Pack 2 (5.0.2.35), RayStation 5 Service Pack 3 (5.0.3.17), RayStation 6/RayPlan 2 (6.0.0.24), RayStation 6/RayPlan 2 Service Pack 1 (6.1.1.2), RayStation 6/RayPlan 2 Service Pack 2 (6.2.0.7), RayStation 6/RayPlan 2 Service Pack 3 (6.3.0.6), RayStation/RayPlan 7 (7.0.0.19), RayStation/RayPlan 8A (8.0.0.61), RayStation/RayPlan 8A Service Pack 1 (8.0.1.10) Software versions: 4.0.0.14, 4.0.3.4, 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, 10.1.1.54, 11.0.0.951, 11.0.1.29, 11.0.3.116 or 12.0.0.932
Reason for recall
Incorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system.
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-0850-2022. 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.