FDA-Device2012-08-22Class II

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).

Sentec AG
Hazard

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

Sold states
Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
Affected count
8
Manufactured in
Ringstrasse 39, Therwil, Baselland, Switzerland
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2199-2012

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