BEUDAMED
    FDA Enforcement Class II Terminated

    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.

    Recall: Z-2775-2016 · Reported September 21, 2016

    Enforcement

    Recall Number
    Z-2775-2016
    Event ID
    74837
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thermo Finnigan LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 21, 2016
    Initiation Date
    July 19, 2016
    Classification Date
    September 9, 2016
    Termination Date
    February 21, 2017
    Address
    355 River Oaks Pkwy, N/A, San Jose, CA, 95134-1908, United States

    Description

    Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.

    Reason

    Thermo Fisher has determined that the Endura MD mass spectrometer instrument control software versions 1.0 and 1.0 SP! have a software defect which affect data accuracy.

    Code Info

    TQH-MD-E0101, THQ-MD-E-0102, TQH-MD-E0103, TQH-MD-E0104, TQH-MD-EMP003, TQH-MD-EMP-002.

    Distribution

    Worldwide distribution - US including FL, NY and Internationally to Japan.

    Quantity

    6 (5 in Us distribuion and 1 in Japan)