BEUDAMED
    FDA Enforcement Class II Completed

    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

    Recall: Z-2283-2018 · Reported July 4, 2018

    Enforcement

    Recall Number
    Z-2283-2018
    Event ID
    80272
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 4, 2018
    Initiation Date
    May 1, 2018
    Classification Date
    June 22, 2018
    Termination Date
    March 18, 2020
    Address
    40 Liberty Blvd, Malvern, PA, 19355-1418, United States

    Description

    ARTIS Pheno Interventional Fluoroscopic X-Ray System, Model 10849000

    Reason

    If the C-arm is manually moved in the longitudinal direction to a fully extended position, the system's safety stop mechanism may be activated. As a result, the C-arm stops the movement and can drop up to 20 mm (0.8 ). Under certain circumstances, the cover of the detector or collimator can touch and possibly injure the patient due to the C-arm drop. This could lead to a situation in which it is necessary to stop the clinical treatment or continue the treatment on an alternative system.

    Code Info

    164033 164071 164034 164095 164057 164055 164054 164080 164072 164088 164048 164094 164068 164019 164013 164073 164027 164026 164025 164060 164083 164021 164066 164075 164084 164086 164074 164098 164028 164053 164063 164064 164024 164049 164022 164018 164100 164097 164011

    Distribution

    Healthcare facilities in AL, CA, CO, FL, IL, KY, MA, MI, MN, MS, NE, NJ, NY, OH, TN, TX, UT, and VA. Foreign distribution to Australia, Austria, Belgium, Denmark, France, Germany, Italy, Japan, Kuwait, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.

    Quantity

    39