BEUDAMED
    FDA Recall Terminated

    HF Cable WA00014A, Endoscopic electrosurgical unit and accessories

    Recall: Z-0754-2017 · Initiated November 3, 2016

    Recall

    Recall Number
    Z-0754-2017
    Event Number
    75601
    Firm
    Olympus Corporation of the Americas
    FEI Number
    2429304
    Product Code
    FAS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 3, 2016
    Terminated
    February 6, 2019
    Address
    3500 Corporate Pkwy PO Box 610, Center Valley, PA, 18034-0610

    Description

    HF Cable WA00014A, Endoscopic electrosurgical unit and accessories

    Reason

    Software malfunction that results in incorrect generation or display of error codes.

    Action

    Olympus mailed on 11/03/2016 an Urgent Communication Letter to customers affected by the recall. The letter requested that consignees inspect their inventory for the affected lots and call Customer Service to obtain a Returned Material Authorization (RMA) to return the product.

    Distribution

    Distributed Nationwide

    Quantity

    494 units