BEUDAMED
    FDA Recall Terminated

    Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover, MA, 01810

    Recall: Z-0124-2008 · Initiated September 12, 2007

    Recall

    Recall Number
    Z-0124-2008
    Event Number
    44824
    Firm
    Philips Medical Systems
    FEI Number
    1218950
    Product Code
    DPS
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    September 12, 2007
    Posted
    January 30, 2008
    Terminated
    August 16, 2016
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips PageWriter Touch Cardiograph, Model: 860284, Philips Medical Systems, Andover, MA, 01810

    Reason

    Incorrect display: When using the 16 lead Patient Interface Module (PIM), lead tracings of V3R and V4R are reversed in the extended lead modes of Pediatric and Balanced.

    Action

    Philips Medical Systems notified affected customers by Customer Letter and Urgent - Device Correction Notice dated 9/12/07. The correction will be a software upgrade. In the US, the Philips Response Center will contact US customers and arrange their upgrades, either via a software download, or by sending a Field Service Engineer to the customer site to perform the upgrade. Until new software is installed, customers are being advised to use the 12 lead module, and to disable or disconnect the 16 lead connection.

    Distribution

    Worldwide Distribution - USA, Canada, Australia, Hungary, New Zealand, Nigeria, Norway, Qatar, Taiwan, and UAE.

    Quantity

    266 units