BEUDAMED
    FDA Enforcement Class II Terminated

    Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

    Recall: Z-0263-2016 · Reported November 18, 2015

    Enforcement

    Recall Number
    Z-0263-2016
    Event ID
    72171
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    NeuroLogica Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 18, 2015
    Initiation Date
    September 14, 2015
    Classification Date
    November 10, 2015
    Termination Date
    January 19, 2017
    Address
    14 Electronics Ave, N/A, Danvers, MA, 01923-1011, United States

    Description

    Samsung GM60A-40S Intended for use in generating radiographic images of human anatomy.

    Reason

    When the system is driving over a non-conductive floor and then over a conductive, grounded part, proper control of the drive behavior may not be possible. The system can be stopped by releasing the drive handle or by pressing the emergency switch. Proper behavior is re-enabled when the system is rebooted.

    Code Info

    Serial Numbers: 50EAM9BG200004X, 50EAM9BG200001A 50EAM9BG200002P, 50EAM9BG200003D, 50EAM9BG200005N, 50EAM9BG200006E, 50EAM9BG200007F

    Distribution

    Distributed to the states of NC, OH, MA, and MO.

    Quantity

    7 devices