BEUDAMED
    FDA Enforcement Class II Terminated

    Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

    Recall: Z-2082-2016 · Reported July 13, 2016

    Enforcement

    Recall Number
    Z-2082-2016
    Event ID
    74153
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medtronic Navigation, Inc.-Littleton
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 13, 2016
    Initiation Date
    March 17, 2016
    Classification Date
    July 6, 2016
    Termination Date
    April 6, 2021
    Address
    300 Foster Street, N/A, Littleton, MA, 01460-2017, United States

    Description

    Medtronic 0-arm Imaging mobile x-ray system. Model Numbers - B1-700-00027, B1-700-00028

    Reason

    It has been discovered that replacement x-ray generator and system motion batteries could become damaged during shipment, resulting in unacceptable risk of failure.

    Code Info

    Model No. BI-700-00027 and BT-700-00028

    Distribution

    Nationwide Distribution

    Quantity

    US - 581