Reported Jun 28, 2023 · Ongoing

V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).

SenTec AG

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: SenTec AG · Ringstrasse 39 · Therwil · N/A

Is this the product you have?

  • V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
Lot codes and dates
    • Serial numbers 338947
    • 338952
    • 338953
    • 338963
    • 338967
    • 338989
    • 338991
    • 338993
    • 338994
    • 338996
    • 338997
    • UDI-DI 07640121880513
Amount recalled
11 in the U.S.

Where it was sold

Why it was recalled

The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

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