BEUDAMED
    FDA Enforcement Class II Terminated

    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    Recall: Z-0757-2016 · Reported February 10, 2016

    Enforcement

    Recall Number
    Z-0757-2016
    Event ID
    73059
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 10, 2016
    Initiation Date
    January 8, 2016
    Classification Date
    February 4, 2016
    Termination Date
    January 9, 2017
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.

    Reason

    Olympus America Inc is conducting a voluntary removal/corrective action of all TJF-Q180V duodenoscopes in order to replace the forceps elevator mechanism Olympus is replacing the forceps elevator mechanism with a new forceps elevator design consistent with the design specification in the recently cleared TJF-Q180V 510k.

    Code Info

    all codes

    Distribution

    US Nationwide Distribution except PR

    Quantity

    4436