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U.S. Department of Health and Human Services

Enforcement Report - Week of August 22, 2012

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Product Detail

Product 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).
Recall Number Z-2199-2012
Classification Class II
Code Info 310701 311100 311239 310996 311920 311943 311958 312132
Product Distributed Qty 8
Reason For Recall SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

Event Detail

Event Id 62589
Product Type Devices
Status Ongoing
Recalling Firm Sentec AG
City Therwil, Baselland
Country CH
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-07-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.