SenTec Recalls V-Sign Sensor 2 Due to Premature PCO2 Unit Deterioration
SenTec AG is voluntarily replacing V-Sign Sensor 2 units because a part of the PCO2 measuring unit deteriorates prematurely, disabling PCO2 monitoring. The recall affects 129 units in the US and 59 outside the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a functional defect (premature end-of-life) where the source explicitly states there is no increased risk to patients or operators, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
SenTec AG is voluntarily recalling and replacing V-Sign Sensor 2 devices (REF VS-A/P/N) due to premature deterioration of a component within the PCO2 measuring unit. This defect causes the sensors to reach their end-of-life earlier than expected, which disables the transcutaneous carbon dioxide tension (tcPCO2) monitoring function. The SenTec Digital Monitoring System (SDMS) is used for continuous, non-invasive monitoring of tcPCO2, oxygen saturation (SpO2), and pulse rate (PR).
The recall involves 129 units distributed in the United States and 59 units distributed outside the US. US distribution was limited to the state of Missouri. The source text states that there is no increased risk for the patient or operator because the deterioration results in the sensor's replacement rather than a hazardous malfunction.
Consumers and healthcare facilities should contact SenTec AG to arrange for the replacement of affected sensors. The recall is voluntary and addresses a functional defect that reduces the device's lifespan and specific monitoring capabilities.
The recalled product
- 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…
- Manufacturer
- SenTec AG
Distribution
Distributed in 1 state:
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