BEUDAMED
    FDA Enforcement Class II Terminated

    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

    Recall: Z-2384-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2384-2012
    Event ID
    62884
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 26, 2012
    Initiation Date
    August 14, 2012
    Classification Date
    September 14, 2012
    Termination Date
    January 17, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810, United States

    Description

    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications

    Reason

    Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm.

    Code Info

    Lot or Serial Numbers With affected M-cabinet CXA; Serial number; 11-K0003; 12-B0001, 12-B0002; 12-B0003

    Distribution

    Worldwide Distribution - USA including OH and WA and the country of Canada

    Quantity

    4 systems