BEUDAMED
    FDA Enforcement Class II Terminated

    Pentax Video Colonoscope Model: EC34-i10L

    Recall: Z-1267-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1267-2020
    Event ID
    84735
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pentax of America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    February 26, 2020
    Initiation Date
    January 3, 2020
    Classification Date
    February 19, 2020
    Termination Date
    January 26, 2021
    Address
    3 Paragon Dr, Montvale, NJ, 07645-1782, United States

    Description

    Pentax Video Colonoscope Model: EC34-i10L

    Reason

    Distributed in the USA without an approved 510K

    Code Info

    Serial Numbers: L110300, L110301, L110303, L110306

    Distribution

    NC, MA