FDA Device recall Z-1749-2024
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119
- FDA Device
- Class II
- ongoing
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119 by Raysearch Laboratories Ab, citing potential for reported SSD to be too high.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1749-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-28 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayStation 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 &12.3.0.119. Radiation Therapy Treatment Planning System.
Reason
Potential for reported SSD to be too high.
Identifiers
| code_info | UDI: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 073500020105702…UDI: 0735000201042620211208, 0735000201049520220312, 0735000201050120220422, 0735000201060020220620 and 0735000201057020221222; GTIN: 07350002010426, 07350002010495, 07350002010501, 07350002010600 and 07350002010570; Serial Numbers: 12.0.0.932, 12.1.0.1221, 12.0.3.68, 12.0.4.12 and 12.3.0.119; Expiration Date: 2028-03-20. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1749-2024%22
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