BEUDAMED
    FDA Enforcement Class II Terminated

    Philips DuraDiagnost stationary X-ray system

    Recall: Z-2682-2016 · Reported September 7, 2016

    Enforcement

    Recall Number
    Z-2682-2016
    Event ID
    74685
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Electronics North America Corporation
    Voluntary / Mandated
    FDA Mandated
    Initial Notification
    Letter
    Report Date
    September 7, 2016
    Initiation Date
    September 17, 2015
    Classification Date
    September 1, 2016
    Termination Date
    August 31, 2017
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips DuraDiagnost stationary X-ray system

    Reason

    Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].

    Code Info

    SN: 140054 140059 150013 150014 150039 150041 150042 150052 150053 150055 150056 150059 150061 150091 150093

    Distribution

    US Distribution to the states of : ME, NE, OR, CA, TX, NC, WA and OH.

    Quantity

    15