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Recall Observatory FDA recall evidence

Device product

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 2024A SP3, Software Version: 15.1.3.10. Product Description: Radiation Therapy Treatment Planning System.

Z-2495-2025

August 08, 2025

Class II

Product summary

Firm
RAYSEARCH LABORATORIES AB
Event
Event 97400
Status
Ongoing
Classification
Class II
Quantity
49
Official record key
device-enforcement:Z-2495-2025

Official wording

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.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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