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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: 310701 311100 311239 310996 311920 311943 311958 312132
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Sentec AG
- Reason for Recall:
- SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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).
Product Codes/Lot Numbers:
310701 311100 311239 310996 311920 311943 311958 312132
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2199-2012
Related Recalls
During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.
V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
SenTec AG
The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.
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