Class II — RAYSEARCH LABORATORIES AB
| Recalling firm | RaySearch Laboratories AB (publ) |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | RayStation with the following product descriptions: 1. RayStation 10B, Software Version: 10.1.0.613. 2. RayStation 10B Service Pack 1, Software Version: 10.1.1.54. Product Description: Radiation Therapy Treatment Planning System. |
| Quantity | 3 |
| Distribution | Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IL, IA, KY, LA, MD, MN, MS, NY, NC, OH, OK, SC, WA, WI and the countries of Canada, China, Colombia, France, Germany, Hong Kong S.A.R., China, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, ENG, Thailand, Turkey, UK, Ukraine. |
| Initiated | 2025-08-08 |
| Classified | 2025-09-02 |
| Recall number | Z-2490-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — RAYSEARCH LABORATORIES AB (Z-2490-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97400/
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