BEUDAMED
    FDA Enforcement Class III Terminated

    AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.

    Recall: Z-0486-2021 · Reported December 2, 2020

    Enforcement

    Recall Number
    Z-0486-2021
    Event ID
    86536
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Advanced Bionics, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 2, 2020
    Initiation Date
    September 26, 2020
    Classification Date
    November 25, 2020
    Termination Date
    May 4, 2023
    Address
    28515 Westinghouse Pl, N/A, Valencia, CA, 91355-1398, United States

    Description

    AB PowerCel 230 (velvet black), REF: CI-5523-150, UDI: (01) 07630016832956 used to power the following devices: Na¿da CI Q90 Sound Processor (CI-5280), Na¿da CI Q70 Sound Processor (CI-5245) and Na¿da CI Q30 Sound Processor (CI-5260) for cochlear implant.

    Reason

    Mislabeling; It has been determined that some batteries were improperly labeled and may contain a different battery life than indicated.

    Code Info

    410079020

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of NY, IL, MA, NE, CA, HI, LA, MS, AL, FL, SC, OH and the countries of Belgium, Germany, Italy Netherlands, Spain, Colombia, Czech Republic, Iran, Kuwait, Panama, Peru, Taiwan, Italy.

    Quantity

    53 units