BEUDAMED
    FDA Enforcement Class II Terminated

    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

    Recall: Z-2290-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2290-2014
    Event ID
    68753
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax Medical Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    July 17, 2014
    Classification Date
    August 21, 2014
    Termination Date
    August 20, 2015
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782, United States

    Description

    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

    Reason

    The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.

    Code Info

    Model No. OF-B130 OF-B194, all units.

    Distribution

    Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.

    Quantity

    98 units US; 1108 units OUS