BEUDAMED
    FDA Recall 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 · Initiated July 9, 2012

    Recall

    Recall Number
    Z-2199-2012
    Event Number
    62589
    Firm
    Sentec AG Ringstrasse 39 Therwil, Baselland Switzerland
    FEI Number
    3004149774
    Product Code
    LKD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 9, 2012
    Posted
    August 13, 2012
    Terminated
    October 11, 2012

    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.

    Action

    SenTec sent a Field Safety Notice dated July 12, 2012, via email to all affected customers. It identified the product the problem and the action needed to be taken by the customer. Customers were instructed the affected Sensors in the field must be replaced. Please locate the affected Sensors and return them to SenTec for analysis immediately. SenTec will provide you with replacement Sensors within the next three months.This notice needs to be passed on to all those who need to be aware within your organization. Please transfer this notice to other organizations on which this action has an impact. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Further questions please call (262 ) 594-2114.

    Distribution

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

    Quantity

    8