BEUDAMED
    FDA Enforcement Class II Ongoing

    HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

    Recall: Z-1813-2025 · Reported May 28, 2025

    Enforcement

    Recall Number
    Z-1813-2025
    Event ID
    96668
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Advanced Bionics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 28, 2025
    Initiation Date
    March 5, 2025
    Classification Date
    May 22, 2025
    Address
    28515 Westinghouse Pl, N/A, Valencia, CA, 91355-1398, United States

    Description

    HiResolution" Bionic Ear System - M Battery Charger Model Number CI-5607

    Reason

    Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.

    Code Info

    M Battery Charger Model Number: CI-5607 UDI-DI code: 00840094433977 Lot Numbers: 410488966; 410488967

    Distribution

    U.S.: AZ, FL, MI, SC, TN and TX. O.U.S.: N/A

    Quantity

    6 chargers