RAYSEARCH LABORATORIES AB: RayStation with the following product descriptions: 1. RayStation 2023B, Software Version: 14.0.0.3338. 2. RayStation 2024A, Software Version: 15.0.0.430. 3. RayStation 2024

Hazard

DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique.

Details from the source

Reason for recall: DICOM SOP Instance UID and Series Instance UID from RayGateway, i.e. the interface to Accuray's iDMS, are not guaranteed to be unique. 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. Quantity: 49 Lot/code info: 1. Software Version: 14.0.0.3338, UDI: 0735000201055620230630. 2. Software Version: 15.0.0.430, UDI: 0735000201072320231213. 3. Software Version: 15.1.3.10, UDI: 0735000201087720241106. Expiration Date: 2030-02-21

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.