RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.
Pending LLM rewrite. Source: FDA_DEVICE Z-2493-2025.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
The recalled product
- Product
- RayStation with the following product descriptions: 1. RayStation 12A, Software Version: 13.0.0.1547. 2. RayStation 12A Service Pack 1, Software Version: 13.1.0.144. 3. RayStation 12A Service Pack 2, Software Version: 13.1.1.89. Product Description: Radiation Thera
- Manufacturer
- RAYSEARCH LABORATORIES AB
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 1. Software Version: 13.0.0.1547
- UDI: 0735000201054920220616. 2. Software Version: 13.1.0.144
- UDI: 0735000201067920221007. 3. Software Version: 13.1.1.89
- UDI: 0735000201073020230913. Expiration Date: 2028-07-07
Distribution
Distributed nationwide across the United States.
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