BEUDAMED
    FDA Enforcement Class II Terminated

    9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal

    Recall: Z-0293-2021 · Reported November 4, 2020

    Enforcement

    Recall Number
    Z-0293-2021
    Event ID
    86440
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2020
    Initiation Date
    September 22, 2020
    Classification Date
    October 23, 2020
    Termination Date
    May 16, 2022
    Address
    3 Paragon Dr, N/A, Montvale, NJ, 07645-1782, United States

    Description

    9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal

    Reason

    There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.

    Code Info

    All systems with version 3.4.0 or higher; Computer Serial Numbers: 84086-01 84533-01 84090-16 84090-15 84090-14 84090-11 84090-09 84090-10 84090-08 84088-13 84088-11 84528-08 84087-06 84087-03 84538-06 84088-14 84089-02 84089-06 84089-03 84529-04 84528-05 81536-06 84091-01 84089-16 81536-12 84532-11 81538-05 84090-02 84089-13 84089-12 84090-06 84087-04 84531-12 84531-11 84531-10 84531-13 84091-16 84533-11 84533-12

    Distribution

    US Nationwide and Canada

    Quantity

    39 total