BEUDAMED
    FDA Recall Terminated

    Nada 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 · Initiated February 6, 2019

    Recall

    Recall Number
    Z-1084-2019
    Event Number
    82241
    Firm
    Advanced Bionics, LLC
    FEI Number
    1000220815
    Product Code
    MCM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 6, 2019
    Terminated
    February 1, 2024
    Address
    28515 Westinghouse Pl, Valencia, CA, 91355-1398

    Description

    Nada 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.

    Action

    On 2/6/2019, the firm began issuing letters dated February 2019 informing the recipient that corrected product was en route.

    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