BEUDAMED
    FDA Enforcement Class II Terminated

    CENTURION Vision System

    Recall: Z-2081-2016 · Reported July 6, 2016

    Enforcement

    Recall Number
    Z-2081-2016
    Event ID
    74282
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Other
    Report Date
    July 6, 2016
    Initiation Date
    May 24, 2016
    Classification Date
    June 28, 2016
    Termination Date
    April 13, 2017
    Address
    6201 South Fwy, Fort Worth, TX, 76134-2099, United States

    Description

    CENTURION Vision System

    Reason

    The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.

    Code Info

    Serial Number 1601444801X

    Distribution

    US Distribution to Illinois

    Quantity

    1 unit