BEUDAMED
    FDA Recall Terminated

    Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide

    Recall: Z-1538-2012 · Initiated October 19, 2011

    Recall

    Recall Number
    Z-1538-2012
    Event Number
    61830
    Firm
    Philips Healthcare Inc.
    FEI Number
    1218950
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    October 19, 2011
    Posted
    June 13, 2012
    Terminated
    January 18, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810

    Description

    Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide

    Reason

    When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. .When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is generated inadvertently. The failure happened when component supplie

    Action

    Philips Healthcare sent a proprosed corrective action letter dated May 3, 2012, to FDA. The proposed corrective action plan is to bring the product into compliance with regulatory requirements by issuing a field corrective action which should be completed by Philips by August 1, 2012. For questions regarding this recall call 978-687-1501.

    Distribution

    Nationwide Distribution

    Quantity

    11 - US