FDA Device recall Z-1299-2022
RayStation 11B
- FDA Device
- Class II
- terminated
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of RayStation 11B by Raysearch Laboratories Ab, citing this notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1299-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-10 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayStation 11B
Reason
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an evaluation dose, LET display might be misleading. Second, a displayed beam-specific LET distribution can sometimes be out of sync with the selected beam.
Identifiers
| code_info | UDI-DI 0735000201042620211208 Software version numbers 12.0.0.932, 12.1.0.1221, 12.0.3.68 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1299-2022%22
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