SenTec AG Recall: Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterp
SenTec AG Recall: Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterp is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: SenTec AG; Product: Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, SenTec AG, CH-4106, Therwil, Switzerland. The SenTec
| Recalling firm | SenTec AG |
|---|---|
| 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 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 II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | US Distribution to the state of : MO |
| Recall initiated | 20150325 |
| Recall number | Z-1501-2015 |
| Category | device |
| Country | Switzerland |
$29/mo
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