BEUDAMED
    FDA Recall Terminated

    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.

    Recall: Z-2051-2014 · Initiated May 28, 2014

    Recall

    Recall Number
    Z-2051-2014
    Event Number
    68581
    Firm
    Shape Medical Systems, Inc
    FEI Number
    3008072932
    Product Code
    BTY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 28, 2014
    Posted
    July 14, 2014
    Terminated
    May 22, 2015
    Address
    5000 Township Pkwy, Saint Paul, MN, 55110-5852

    Description

    Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardiopulmonary exercise testing where collection and review of gas exchange variables are indicated. The system will provide physiological data to physicians to aid in patient assessment.

    Reason

    Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment.

    Action

    Shape Medical Systems sent an Urgent Medical Device Correction letter dated June 17, 2014, to all affected customers. Customers were informed that new orders of the Disposable Patient interface devices (DPI) will require a software upgrade for the Shape HF Cardiopulmonary Testing System prior to using the new DPIs. Impacted DPIs will be shipped with Instructions to conduct the software upgrade and Technical Service will contact customers shipped the impacted DPIs to confirm receipt and assist with the software upgrade. A Response Form was requested to be returned. Customers with questions were instructed to call Shape Technical Service at 1-888-906-6266 or 651-621-2990.

    Distribution

    Nationwide Distribution

    Quantity

    800