Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse rate (PR).
Class I - DangerousWhat Should You Do?
- Check if you have this product: 315.105 315.106 315.107 315.108 315.109 315.111 315.112 315.113 315.114 315.115 315.116 315.117 315.118 315.119 315.120 315.122 315.123 315.124 315.125 315.126 315.127 315.128 315.285 315.286 315.287 315.288 315.289 315.290 315.291 315.292 315.294 315.295 315.296 315.297 315.298 315.299 315.300 315.301 315.302 315.303 315.305 315.306 315.307 315.308 315.309 315.310 315.311 315.312 315.313 315.314 315.275 315.276 315.277 315.278 315.279 315.280 315.281 315.282 315.283 315.284 315.597 315.599 315.600 315.601 315.602 315.603 315.604 315.605 315.606 315.607 315.610 315.611 315.561 315.562 315.563 315.564 315.565 315.566 315.567 315.568 315.569 315.571 315.572 315.573 315.574 Expanded: 314.804 314.813 314.815 314.820 315.414 315.415 315.416 315.417 315.418 315.419 315.420 315.421 315.422 315.423 315.424 315.425 315.426 315.427 315.428 315.429 315.430 315.431 315.432 315.433 315.434 315.435 315.436 315.437 315.438 315.439 315.440 315.441 315.442 315.443 315.445 315.446 315.447 315.448 315.449 315.450 315.452 315.453 315.454 315.455 315.456 315.457 315.458 315.459
- 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 voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement. There is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens
- 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 Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec Digital Monitoring System (SDMS) is used for continuous and non-invasive monitoring of transcutaneous carbon dioxide tension (tcPCO2), oxygen saturation (SpO2), and pulse rate (PR).
Product Codes/Lot Numbers:
315.105 315.106 315.107 315.108 315.109 315.111 315.112 315.113 315.114 315.115 315.116 315.117 315.118 315.119 315.120 315.122 315.123 315.124 315.125 315.126 315.127 315.128 315.285 315.286 315.287 315.288 315.289 315.290 315.291 315.292 315.294 315.295 315.296 315.297 315.298 315.299 315.300 315.301 315.302 315.303 315.305 315.306 315.307 315.308 315.309 315.310 315.311 315.312 315.313 315.314 315.275 315.276 315.277 315.278 315.279 315.280 315.281 315.282 315.283 315.284 315.597 315.599 315.600 315.601 315.602 315.603 315.604 315.605 315.606 315.607 315.610 315.611 315.561 315.562 315.563 315.564 315.565 315.566 315.567 315.568 315.569 315.571 315.572 315.573 315.574 Expanded: 314.804 314.813 314.815 314.820 315.414 315.415 315.416 315.417 315.418 315.419 315.420 315.421 315.422 315.423 315.424 315.425 315.426 315.427 315.428 315.429 315.430 315.431 315.432 315.433 315.434 315.435 315.436 315.437 315.438 315.439 315.440 315.441 315.442 315.443 315.445 315.446 315.447 315.448 315.449 315.450 315.452 315.453 315.454 315.455 315.456 315.457 315.458 315.459
Distribution:
Distributed in: US, MO
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1501-2015
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.
Weak skin adhesion.