BEUDAMED
    FDA Enforcement Class I Terminated

    King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12

    Recall: Z-0916-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-0916-2020
    Event ID
    84415
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    King Systems Corp. dba Ambu, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 12, 2020
    Initiation Date
    November 5, 2019
    Classification Date
    February 4, 2020
    Termination Date
    March 23, 2021
    Address
    15011 Herriman Blvd, N/A, Noblesville, IN, 46060-4253, United States

    Description

    King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12

    Reason

    Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.

    Code Info

    Lot codes: 010614, 010629, 010657, 010668, 010670, 010722; Serial Numbers: LHXXXXXXX10240 LHXXXXXXX10243 LHXXXXXXX10284 LHXXXXXXX10554 LHXXXXXXX10559 LHXXXXXXX10562 LHXXXXXXX10569 LHXXXXXXX10570 LHXXXXXXX10611 LHXXXXXXX10666

    Distribution

    Worldwide distribution. US Nationwide, Australia, Belgium, Bolivia, Canada, Costa Rica, Germany, Hong Kong, India, Italy, Japan, Myanmar, Poland, Spain, and UK.

    Quantity

    171 units