BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2384-2012 · Initiated August 14, 2012

    Recall

    Recall Number
    Z-2384-2012
    Event Number
    62884
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    MQB
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 14, 2012
    Posted
    September 14, 2012
    Terminated
    January 17, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    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.

    Action

    Philips Healthcare Imaging issued an Urgent - Field Safety Notice dated August 8, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The unit will be exchanged with a new unit that complies with the IEC requirements. Please reference Field Change Order (FCO) 71200081 when contacting I your local Philips representative. 1-800-722-9377. Customer were instructed to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter and to maintain a copy of the letter with the equipment instruction for Use. For further assistance, customers should contact their local Phillips representative: Technical Support Line 1-800-722-9377. For questions regarding this recall call 978-687-1501.

    Distribution

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

    Quantity

    4 systems