BEUDAMED
    FDA Recall 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 · Initiated November 5, 2019

    Recall

    Recall Number
    Z-0916-2020
    Event Number
    84415
    Firm
    King Systems Corp. dba Ambu, Inc.
    FEI Number
    1824226
    Product Code
    CCW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 5, 2019
    Posted
    February 4, 2020
    Terminated
    March 23, 2021
    Address
    15011 Herriman Blvd, Noblesville, IN, 46060-4253

    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.

    Action

    King Systems issued notification letter -Urgent Medical Device Recall to Domestic consignees notified via E-mail on 11/5/19 with attached letters and forms. Foreign consignees were notified according to local regulation. On January 24, 2020, King Systems issued a Press Release dated 1/20/2020. Customers are advised to take the following action: 1) Review your current inventory and place any affected products in quarantine immediately. 2) The affected products should NOT be used. 3) Please note any affected quantity of product(s) on the attached form and return it within 30 days from the date of this letter by email to Shelby Mitchell ([email protected]). King Systems asks that you please return all affected product(s). Please contact Shelby Mitchell at +l (410) 768-6464 or email [email protected] to arrange Return Authorization and credit/replacement

    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