BEUDAMED
    FDA Recall Terminated

    Video Cytoscopes

    Recall: Z-2325-2017 · Initiated January 11, 2011

    Recall

    Recall Number
    Z-2325-2017
    Event Number
    77310
    Firm
    Pentax of America Inc
    FEI Number
    1000080301
    Product Code
    EOQ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 11, 2011
    Terminated
    March 13, 2018
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782

    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.

    Action

    Customers were visited by members of Pentax America, Inc. field service team. The field service technicians inspected the affected devices, and documented the inspections using the Inspection Record Form (QS-397).

    Distribution

    US Nationwide and Internationally

    Quantity

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