BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1538-2012 · Reported June 20, 2012

    Enforcement

    Recall Number
    Z-1538-2012
    Event ID
    61830
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips Healthcare Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 20, 2012
    Initiation Date
    October 19, 2011
    Classification Date
    June 13, 2012
    Termination Date
    January 18, 2017
    Address
    3000 Minuteman Road, Andover, MA, 01810, United States

    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

    Distribution

    Nationwide Distribution

    Quantity

    11 - US