BEUDAMED
    FDA Enforcement Class II Terminated

    Na¿da CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.

    Recall: Z-1083-2019 · Reported April 10, 2019

    Enforcement

    Recall Number
    Z-1083-2019
    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 CL Q30 Sound Processor, Sand Beige, Model Cl-5260-120; Silver Gray, Model Cl-5260-140; and Velvet Black, Model Cl-5260-150.

    Reason

    The sound processors were loaded with the incorrect firmware.

    Code Info

    Model Cl-5260-120 - Serial number 1047584, UDI (01)07630016838057(11)180309(21)1045784; Model Cl-5260-140 - Serial number 1047481, UDI (01)07630016829710(11)151208(21)1047481; and Serial number 1047482, UDI (01)07630016829710(11)151208(21)1047482; and Model Cl-5260-150 - Serial number 1082276, UDI (01)07630016838071(11)180925(21)1082276.

    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

    4 sound processors