BEUDAMED
    FDA Enforcement Class II Terminated

    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.

    Recall: Z-1060-2015 · Reported February 11, 2015

    Enforcement

    Recall Number
    Z-1060-2015
    Event ID
    70149
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Shape Medical Systems, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 11, 2015
    Initiation Date
    December 23, 2014
    Classification Date
    February 5, 2015
    Termination Date
    April 14, 2015
    Address
    5000 Township Pkwy, N/A, Saint Paul, MN, 55110-5852, United States

    Description

    Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors parameters during laboratory or clinical conditions.

    Reason

    This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted product.

    Code Info

    Lot Numbers: 1412001, 1412002, 1412003 and 1412004

    Distribution

    Distributed in the states of AZ, FL, GA, MA, MN, NJ. NY, PA, TX, and WI.

    Quantity

    564 devices