BEUDAMED
    FDA Recall Open, Classified

    Snapshot NIR, REF: KD204

    Recall: Z-0789-2024 · Initiated October 30, 2023

    Recall

    Recall Number
    Z-0789-2024
    Event Number
    93624
    Firm
    KENT IMAGING, INC.
    FEI Number
    3009771004
    Product Code
    MUD
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 30, 2023
    Posted
    January 25, 2024
    Address
    1210 8 Street SW, Suite 300, Calgary Canada

    Description

    Snapshot NIR, REF: KD204

    Reason

    Tissue oxygenation measurement system touchscreens may be unresponsive, which may prevent the viewing of oxygenation images.

    Action

    On 10/30/23, recall notices were mailed and emailed to customers who were asked to do the following: Customers are asked to choose two ways to obtain replacement devices. Either the firm will ship replacement devices to customers and customers will ship affected devices back to the firm, or 2) Firm personnel will exchange devices through visit. Customer with questions can contact the firm via phone, 1-403-455-7610, or via their website, https://www.kentimaging.com/contact

    Distribution

    Worldwide - US Nationwide distribution in the states of IN, OH, TX, PA, WI, OR, CO, IL, MO, CA, AZ, IA and the countries of Malaysia.

    Quantity

    57