FDA Device recall Z-1427-2021
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (…
- FDA Device
- Class II
- ongoing
- Published 2021-04-21
On 2021-04-21 the FDA classified a Class II recall of RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (… by Raysearch Laboratories Ab, citing flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1427-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-03-25 |
| Published | 2021-04-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayStation Model Number: (9A)9.0.0.113, 9B (9.1.0.933), 9B Service pack (9.2.0.483), 10A (10.0.0.1154), 10A Service pack (10.0.1.52), 10B (10.1.0.613)
Reason
Flags edited in RayCare after a patient has been checked in may not always be updated in RayTreat.
Identifiers
| code_info | Software version: 9A, 9B, 10A, 10B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1427-2021%22
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