BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.

    Recall: Z-2208-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2208-2012
    Event ID
    62568
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    July 11, 2012
    Classification Date
    August 15, 2012
    Termination Date
    January 23, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810, United States

    Description

    Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.

    Reason

    Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.

    Code Info

    Serial Numbers: SN07000141 SN07000109 SN5000162 SN5000421 SN07000667 200148 200115 200081 300114

    Distribution

    Worldwide Distribution - USA including IN, MA, MI, MO, NC, NY PA, SC, and WI and to the countries of Canada, HongKong, New Zealand.

    Quantity

    12 units