V-Sign Sensor 2 May Experience Out-of-Box Failure Due to Software Configuration
The V-Sign Sensor 2, a component of the Sentec Digital Monitoring System, may fail out of the box due to improper software mode configuration after recalibration. Approximately 11 units were distributed in select U.S. states.
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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a software configuration issue with theoretical risk; no actual out-of-box failures have been reported, making this a precautionary recall.
Plain-English summary
SenTec AG is recalling the V-Sign Sensor 2 (reference VS-A/P/N), a component of the Sentec Digital Monitoring System. Approximately 11 units were distributed in the United States.
The sensors may experience an out-of-box failure because after recalibration, they remained in the software mode "production" instead of being reset to "released" mode. This configuration error may prevent the sensors from functioning properly.
The affected units were distributed in California, Florida, Illinois, Massachusetts, Mississippi, Montana, Nevada, and Texas. The specific serial numbers involved are 338947, 338952, 338953, 338963, 338967, 338989, 338991, 338993, 338994, 338996, and 338997.
The recalled product
- Product
- V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
- Manufacturer
- SenTec AG
- Affected units
- 11
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 (12)
- Serial numbers 338947
- 338952
- 338953
- 338963
- 338967
- 338989
- 338991
- 338993
- 338994
- 338996
- 338997
- UDI-DI 07640121880513.
Distribution
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