Recall Z-1501-2015— SenTec AG
Class II · Terminated
Class II FDA medical device recall by SenTec AG, initiated 2015-03-25, terminated 2016-02-05. It names one FDA 510(k) clearance: K101690. 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).. Reason: 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.
- Recalling firm
- SenTec AG
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-25
- Terminated
- 2016-02-05
- Firm location
- 4106 Therwil, Switzerland
510(k) clearances named in this recall
1 on FDA's record- K101690 — SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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).
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.