BEUDAMED
    FDA Enforcement Class II Terminated

    Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.

    Recall: Z-1933-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1933-2020
    Event ID
    85473
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Philips North America, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    April 10, 2020
    Classification Date
    May 8, 2020
    Termination Date
    January 11, 2021
    Address
    3000 Minuteman Rd, N/A, Andover, MA, 01810-1032, United States

    Description

    Philips Zenition 70, System code 718133 - Product Usage: The devices are used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device.

    Reason

    When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.

    Code Info

    Serial Numbers 35 37 56 20 50 2 7 8 10 12 13 47 67 34 19 31 45 86 30 59 51 21 54

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of MD and MI. The countries of Austria, Belgium, France, Germany, Netherlands, Norway, South Africa, Spain, Switzerland, and United Kingdom.

    Quantity

    25 total