SenTec Recalls V-Sign 2 Sensors Due to Configuration Parameter Writing Errors
Sentec AG is recalling V-Sign 2 Sensors because of a problem with configuration parameter writing during manufacturing.
What this means for you
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 classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or specific high-risk pathogens. It describes a manufacturing configuration issue without explicit reports of harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sentec AG is recalling a number of V-Sign 2 Sensors. These sensors are part of the SenTec Digital Monitoring System (SMDS), which is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
The recall is being conducted due to a problem regarding configuration parameter writing during the manufacturing process. The source text does not specify the exact nature of the configuration error or the specific clinical risks associated with it.
The affected units were distributed worldwide, including in the United States (specifically mentioning Missouri) and in Germany, Spain, France, Netherlands, Australia, Belgium, and Thailand. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it state if any injuries or illnesses have been reported.
The recalled product
- Product
- SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is used for continuous and noninvasive real-time monitoring of ventilation (tcPCO2) and oxygenation (SpO2).
- Manufacturer
- Sentec AG
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 310701 311100 311239 310996 311920 311943 311958 312132
Distribution
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