RayStation Software Version Numbers version numbers 8B — Class II medical device recall Z-1482-2024
Ongoing recall by RAYSEARCH LABORATORIES AB, reported 2024-04-17, distributed nationwide. A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrec
| Recall number | Z-1482-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | RAYSEARCH LABORATORIES AB, Stockholm, N/A, Sweden |
| Recall initiated | 2024-02-23 |
| Classified | 2024-04-05 |
| Reported by FDA | 2024-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CA, CH, CN, CO, CY, CZ, DE, DK, EE, EG, ES, FR, GB, HK, HU, ID, IL, IN, IT, JP, KR, MA, MY, NL, NO, NZ, PL, QA, SE, SG, SI, TH, TR, TW, ZA |
| Quantity | 154 units |
| UPC / GTIN / UDI-DI | 07350002010129, 07350002010174, 07350002010204, 07350002010235, 07350002010266, 07350002010297, 07350002010303, 07350002010310, 07350002010365, 07350002010389, 07350002010426, 07350002010433, 07350002010440, 07350002010471, 07350002010488, 07350002010495, 07350002010501, 07350002010549, 07350002010556, 07350002010570, 07350002010587, 07350002010600, 07350002010617, 07350002010631, 07350002010655 and 6 more |
Product
RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.
Reason for recall
A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant.
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-1482-2024. 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.