Recall Z-1482-2024— RAYSEARCH LABORATORIES AB
Class II · Ongoing
Class II FDA medical device recall by RAYSEARCH LABORATORIES AB, initiated 2024-02-23. It names 6 FDA 510(k) clearances: K222312, K220141, K211867 and 3 more. Product: RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A, 11B, 12A, 12B, 2023B, 2024A including some service packs.. Reason: A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si, was incorrectly selected for a silicone gel polymer implant..
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-02-23
- Firm location
- Stockholm, N/A, Sweden
510(k) clearances named in this recall
6 on FDA's record- K222312 — RayStation 12A
- K220141 — RayStation 11B
- K211867 — RayStation 11.0
- K210645 — RayStation 10.1
- K200569 — RayStation
- K190387 — RayStation
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.