BEUDAMED
    FDA Enforcement Class II Ongoing

    RayStation 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.

    Recall: Z-1747-2024 · Reported May 8, 2024

    Enforcement

    Recall Number
    Z-1747-2024
    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 10.1.0.613 and 10.1.1.54. Radiation Therapy Treatment Planning System.

    Reason

    Potential for reported SSD to be too high.

    Code Info

    UDI: 0735000201031020201216 and 0735000201047120220128; GTIN: 07350002010310 and 07350002010471; Serial Numbers: 10.1.0.613 and 10.1.1.54; Expiration Date: 2027-02-01.

    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

    18 units