BEUDAMED
    FDA Recall 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 · Initiated November 15, 2012

    Recall

    Recall Number
    Z-0820-2013
    Event Number
    64111
    Firm
    Viterion TeleHealthcare Llc
    FEI Number
    3003962513
    Product Code
    MWI
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 15, 2012
    Posted
    February 14, 2013
    Terminated
    February 16, 2017
    Address
    555 White Plains Rd, Tarrytown, NY, 10591-5101

    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.

    Action

    Bayer Healthcare sent "IMPORTANT RECALL INFORMATION" to all affected customers.The letter identified the product, problem, and actions to be taken by the customers. Contact Viterion Support at 1-800-866-0133 option 1 for questions relating to this issue.

    Distribution

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

    Quantity

    Domestic: 19,106 units; Foreign: 267 units