BEUDAMED
    FDA Recall Terminated

    CENTURION Vision System

    Recall: Z-2081-2016 · Initiated May 24, 2016

    Recall

    Recall Number
    Z-2081-2016
    Event Number
    74282
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 24, 2016
    Posted
    June 28, 2016
    Terminated
    April 13, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    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.

    Action

    Alcon has already notified the affected customer verbally on May 24, 2016, and via written correspondence on June 1, 2016. The device was corrected on May 26, 2016, and the Power Entry Switch that was removed from the customers CENTURION Vision System did not exhibit a grounding pin susceptible to detachment. For further questions, please call (817) 293-0450.

    Distribution

    US Distribution to Illinois

    Quantity

    1 unit