BEUDAMED
    FDA Enforcement Class II Terminated

    Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.

    Recall: Z-1085-2019 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-1085-2019
    Event ID
    82241
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Bionics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 10, 2019
    Initiation Date
    February 6, 2019
    Classification Date
    April 3, 2019
    Termination Date
    February 1, 2024
    Address
    28515 Westinghouse Pl, N/A, Valencia, CA, 91355-1398, United States

    Description

    Na¿da CI Q90 Sound Processor, Silver Gray, Model Cl-5280-140.

    Reason

    The sound processors were loaded with the incorrect firmware.

    Code Info

    Serial number 1066444, UDI (01)07630016838118(11)180725(21)1066444.

    Distribution

    Distribution was made to NC. Foreign distribution was made to Canada, Argentina, Germany, South Africa, Egypt, Kuwait, and Iran. There was no government/military distribution.

    Quantity

    1 sound processor