BEUDAMED
    FDA Enforcement Class II Terminated

    Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.

    Recall: Z-0094-2019 · Reported October 17, 2018

    Enforcement

    Recall Number
    Z-0094-2019
    Event ID
    81085
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Widex A/S
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 17, 2018
    Initiation Date
    August 31, 2018
    Classification Date
    October 10, 2018
    Termination Date
    December 21, 2018
    Address
    Nymollevej 6, Lynge, N/A, Denmark

    Description

    Widex BABY hearing aid (referred to as BABY440), powered by zinc-air batteries size 10 Intended use: BABY440 is intended for, but not limited to, babies (0 to 3 years of age) to be used as air conduction amplification devices in everyday listening environments.

    Reason

    The reason for this field action is due to the mounting of a non-tamper-resistant (ordinary) battery drawer on some BABY440 hearing aids. The correct battery drawer is tamper-resistant and require a special tool to open it.

    Code Info

    Serial numbers 024569 and 024550

    Distribution

    US Distribution to states of: GA and NY.

    Quantity

    2