FDA Device recall Z-1742-2024
RayStation 8.0.0.61, 8.0.1.10
- FDA Device
- Class II
- ongoing
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of RayStation 8.0.0.61, 8.0.1.10 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-1742-2024 |
| 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 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.
Reason
Potential for reported SSD to be too high.
Identifiers
| code_info | UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.…UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10 Software Revisions: RayStation/RayPlan 8A and 8A Service Pack 1; Expiration Date: 2023-10-04. |
|---|
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-1742-2024%22
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