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).
Reported: August 22, 2012 Initiated: July 9, 2012 #Z-2199-2012
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).
Reason for Recall
SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
Details
- Recalling Firm
- Sentec AG
- Units Affected
- 8
- Distribution
- Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
- Location
- Therwil, Baselland
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Sentec AG. Units affected: 8.
Why was this product recalled? ▼
SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2012. Severity: Moderate. Recall number: Z-2199-2012.
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