BEUDAMED
    FDA Recall Terminated

    Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.

    Recall: Z-1090-2007 · Initiated June 4, 2007

    Recall

    Recall Number
    Z-1090-2007
    Event Number
    38154
    Firm
    Medtronic Perfusion Systems
    FEI Number
    1000116158
    Product Code
    DTQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 4, 2007
    Posted
    July 23, 2007
    Terminated
    March 2, 2008
    Address
    7611 Northland Dr N, Brooklyn Park, MN, 55428-1088

    Description

    Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Manufactured by: RanD S.r.l 41036 Mendolla (MO) Italy. Distributed exclusively by Medtronic, Inc.

    Reason

    Device failure requiring use of back up systems (malfunctioning printed circuit board (PCB))

    Action

    There are two separate letters dated June 4, 2007 for the customers, based on the configuration of the unit being inspected/updated in the field. These letters explains the situaiton and informs the customers that Medtronic will be visiting each customer site to inspect/update the units. Medtronic Service Technicians will complete a Field Action Certicate acknowledging the successful completion of the update.

    Distribution

    Worldwide Distribution: USA including states of PA, ND, MN, CA, AL, CO, MI, NY, AZ, and OH and countries of Sweden, Iceland, Latvia, Germany, Italy, Austria, Belgium, and France.

    Quantity

    24 units