FDA Device recall Z-2488-2025
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software…
- FDA Device
- Class II
- ongoing
- Published 2025-09-10
On 2025-09-10 the FDA classified a Class II recall of RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software… by Raysearch Laboratories Ab, citing DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2488-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-08 |
| Published | 2025-09-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Raysearch Laboratories Ab |
| Distribution | US |
Product
RayStation with the following product descriptions: 1. RayStation 8B, Software Version: 8.1.0.47. 2. RayStation 8B Service Pack 1, Software Version: 8.1.1.8. 3. RayStation 8B Service Pack 2, Software Version: 8.1.2.5. 4. RayStation 9A, Software Version: 9.0.0.113. 5. RayStation 9A Service Pack 1, Software Version: 9.0.1.142. Product Description: Radiation Therapy Treatment Planning System.
Reason
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Identifiers
| code_info | 1. Software Version: 8.1.0.47, UDI: 0735000201012920181209. 2. Software Version: 8.1.1.8, UDI: 0735000201020420190214.…1. Software Version: 8.1.0.47, UDI: 0735000201012920181209. 2. Software Version: 8.1.1.8, UDI: 0735000201020420190214. 3. Software Version: 8.1.2.5, UDI: 0735000201023520190524. 4. Software Version: 9.0.0.113, UDI: 0735000201017420190612. 5. Software Version: 9.0.1.142, UDI: 0735000201048820220420. Expiration Date: 2027-12-15 |
|---|
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-2488-2025%22
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