FDAFDA · Food and drugs·Recall number Z-2199-2012
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).
Published August 22, 2012 · Recall initiated: July 9, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sentec AG
- Distributor
- Worldwide Distribution -- Nationwide including the state of Missouri,. and the countries of Germany, Spain, France, Netherlands, Australia, Belgium, Thailand.
- Lot
- 310701 311100 311239 310996 311920 311943 311958 312132
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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