BEUDAMED
    FDA Enforcement Class II Terminated

    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    Recall: Z-0820-2013 · Reported February 20, 2013

    Enforcement

    Recall Number
    Z-0820-2013
    Event ID
    64111
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Viterion TeleHealthcare Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 20, 2013
    Initiation Date
    November 15, 2012
    Classification Date
    February 14, 2013
    Termination Date
    February 16, 2017
    Address
    555 White Plains Rd, Tarrytown, NY, 10591-5101, United States

    Description

    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.

    Reason

    Viterion telehealth monitors do not transmit "HI" (above the meter's measurable range) and "LO" (below the meter's measurable range) blood glucose readings from Bayer's Contour Elite XL blood glucose meters, or from Roche's Accu-Chek Advantage 03 and 04 meters to healthcare professionals.

    Code Info

    All units are affected. List of affected serial numbers were provided as Excel spreadsheet due to the large volume.

    Distribution

    Worldwide Distribution-USA (nationwide) and the United Kingdom.

    Quantity

    Domestic: 19,106 units; Foreign: 267 units