BEUDAMED
    FDA Enforcement Class II Ongoing

    RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.

    Recall: Z-1742-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1742-2024
    Event ID
    94388
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    May 8, 2024
    Initiation Date
    March 28, 2024
    Classification Date
    May 1, 2024
    Address
    Eugeniavagen 18c, Stockholm, N/A, Sweden

    Description

    RayStation 8.0.0.61, 8.0.1.10. Radiation Therapy Treatment Planning System.

    Reason

    Potential for reported SSD to be too high.

    Code Info

    UDI: 0735000201011220180608 and 0735000201013620180928; GTIN: 07350002010112 and 07350002010136; Serial Numbers: 8.0.0.61 and 8.0.1.10 Software Revisions: RayStation/RayPlan 8A and 8A Service Pack 1; Expiration Date: 2023-10-04.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, France, Germany, Hungary, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Morocco, Netherlands, New Zealand, Norway, Poland, Qatar, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, UK.

    Quantity

    9 units