Safety Alert: Class II: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
healthClass IIRecalled on Sep 10, 2025
RayStation with the following product descriptions: 1. RayStation 6 Service Pack 1, Software Version: 6.1.1.2. 2
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Sold At: RAYSEARCH LABORATORIES AB(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.)
Recall #: FDA-DEVICE-Z-2494-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 1. Software Version: 6.1.1.2, UDI: 0735000201008220170529. 2. Software Version: 6.2.0.7, UDI: 0735000201007520170630. 3. Software Version: 6.3.0.6, UDI: 0735000201024220190923. Expiration Date: 2024-10-18
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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.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact RAYSEARCH LABORATORIES AB for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.