RAYSEARCH LABORATORIES AB — 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.
⚠️ DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 8, 2025
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.
What's affected?
- 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 Therapy Treatment Planning System.
- Lot code
- 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
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 13.
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