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SenTec AG recalls Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. T
Recalled April 29, 2015 · FDA recall Z-1501-2015 · SenTec AG
Hazard
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 · FDA Class II
Units
129 US, 59 OUS
Sold at
US Distribution to the state of : MO
Description
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
Product
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).
Manufacturer(s)
SenTec AG
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →