BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1813-2025 · Initiated March 5, 2025

    Recall

    Recall Number
    Z-1813-2025
    Event Number
    96668
    Firm
    Advanced Bionics, LLC
    FEI Number
    1000220815
    Product Code
    MCM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 5, 2025
    Posted
    May 22, 2025
    Address
    28515 Westinghouse Pl, Valencia, CA, 91355-1398

    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.

    Action

    On 03/06/2025, customer service informed customers via telephone call of a distribution error. An updated "URGENT: Medical Device Recall Notification will be communicated to customers on or about 04/09/2025, via email. This updated notification will inform them that upon further review/investigation, it was identified that the individual package label was for the Marvel M Battery Charger (CI-5607), however the product within the package was a Naida CI PowerCel Charger (CI-5605). Customer are informed that: 1. The mislabeled battery charger they received was from lot either Lot Numbers: 410488967 and/or 410488966 Customers are instructed to: 2. Return the affected chargers to Advance Bionics. Advance Bionics will provide the correct charger to customer and will confirm receipt and return of the affected chargers. For questions contact customer service at 877-829-0026 or email [email protected]

    Distribution

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

    Quantity

    6 chargers