BEUDAMED
    FDA Enforcement Class II Ongoing

    Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000

    Recall: Z-2628-2023 · Reported October 4, 2023

    Enforcement

    Recall Number
    Z-2628-2023
    Event ID
    92886
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ambu Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    October 4, 2023
    Initiation Date
    July 21, 2023
    Classification Date
    September 22, 2023
    Address
    6721 Columbia Gateway Dr Ste 200, N/A, Columbia, MD, 21046-3380, United States

    Description

    Ambu aView 2 A Monitor-The Ambu aView 2 Advance is intended to display live imaging data from compatible Ambu visualization devices, portable endoscopy system. Catalog No: 405011000

    Reason

    Multiple impacts, for example from being dropped, can cause to the Ambu aView 2 Advance to short-circuit and under special circumstances make the lithium-ion battery in the device combust leading to smoke and flames

    Code Info

    UDI: 5707480145089 Version no.: 054 thru 056; 058 thru 059 Product manufactured prior to Oct 29, 2020

    Distribution

    Nationwide

    Quantity

    2689 units