Reported Sep 10, 2025 · Ongoing
RayStation with the following product descriptions
Raysearch Laboratories Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: RAYSEARCH LABORATORIES AB · Eugeniavagen 18c · Stockholm, N/A · N/A
Is this the product you have?
RayStation with the following product descriptions
5 of 5 products
| # | Product as published |
|---|---|
| 1 | RayStation 11B, Software Version: 12.0.0.932. |
| 2 | RayStation 11B Service Pack 1, Software Version: 12.1.0.1221. |
| 3 | RayStation 11B Service Pack 2, Software Version: 12.0.3.68. |
| 4 | RayStation 11B Service Pack 3, Software Version: 12.0.4.12. |
| 5 | RayStation 11B Service Pack Toshiba 1, Software Version: 12.3.0.119. Product Description: Radiation Therapy Treatment Planning System. |
- Lot codes and dates
- 1
- Software Version12.0.0.932
- UDI0735000201042620211208. 2
- Software Version12.1.0.1221
- UDI0735000201049520220312. 3
- Software Version12.0.3.68
- UDI0735000201050120220422. 4
- Software Version12.0.4.12
- UDI0735000201060020220620. 5
- Software Version12.3.0.119
- UDI0735000201057020221222
- Expiration Date2028-03-20
- Amount recalled
- 6
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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