BEUDAMED
    FDA Enforcement Class II 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 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2051-2014
    Event ID
    68581
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shape Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    July 23, 2014
    Initiation Date
    May 28, 2014
    Classification Date
    July 14, 2014
    Termination Date
    May 22, 2015
    Address
    5000 Township Pkwy, N/A, Saint Paul, MN, 55110-5852, United States

    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.

    Code Info

    DPIs with Lot Number 1405006 and higher.

    Distribution

    Nationwide Distribution

    Quantity

    800