BEUDAMED
    FDA Enforcement Class II Terminated

    Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

    Recall: Z-2128-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2128-2020
    Event ID
    85572
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Siemens Medical Solutions USA, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    April 17, 2020
    Classification Date
    May 26, 2020
    Termination Date
    August 25, 2020
    Address
    40 Liberty Blvd, N/A, Malvern, PA, 19355, United States

    Description

    Cios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194

    Reason

    The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.

    Code Info

    Serial Numbers: 50135 50131 50171 50129 50048 50184 50180 50136 50185 50153 50155 50130 50127 50134 50166 50192 50161 50128 50132 50160

    Distribution

    US Nationwide Distribution to states of: AR, AZ, CA, FL, IL, IN, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OH, OK, SC, TN, TX, UT, VA, WA, and Puerto Rico.

    Quantity

    20