BEUDAMED
    FDA Enforcement Class II Terminated

    Na¿da CI Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.

    Recall: Z-1084-2019 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-1084-2019
    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 Q70 Sound Processor, Sand Beige, Model Cl-5245-120; Silver Gray, Model Cl-5245-140; and Velvet Black, Model Cl-5245-150.

    Reason

    The sound processors were loaded with the incorrect firmware.

    Code Info

    Model Cl-5245-120 - Serial number 1042838, UDI (01)07630016837814(11)150729(21)1042838; Model Cl-5245-140 - Serial number 1013129, UDI (01)07630016838262(11)181030(21)1013129; and Model Cl-5245-150 - Serial number 1033132, UDI (01)07630016838279(11)170525(21)1033132.

    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

    3 sound processors