BEUDAMED
    FDA Enforcement Class II Terminated

    SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).

    Recall: Z-2199-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2199-2012
    Event ID
    62589
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sentec AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    July 9, 2012
    Classification Date
    August 13, 2012
    Termination Date
    October 11, 2012
    Address
    Ringstrasse 39, Therwil, Baselland, N/A, Switzerland

    Description

    SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).

    Reason

    SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

    Code Info

    310701 311100 311239 310996 311920 311943 311958 312132

    Distribution

    Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.

    Quantity

    8