BEUDAMED
    FDA Enforcement Class II Terminated

    Video Cytoscopes

    Recall: Z-2325-2017 · Reported June 21, 2017

    Enforcement

    Recall Number
    Z-2325-2017
    Event ID
    77310
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    June 21, 2017
    Initiation Date
    January 11, 2011
    Classification Date
    June 9, 2017
    Termination Date
    March 13, 2018
    Address
    3 Paragon Dr, N/A, Montvale, NJ, 07645-1782, United States

    Description

    Video Cytoscopes

    Reason

    This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011.

    Code Info

    Model #'s:ECY-1570 and ECY-1570K

    Distribution

    US Nationwide and Internationally

    Quantity

    1,349 - (Total - US) and 352 (Total - OUS)