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

Recall date

May 2, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1980-2023

FDA classification

Class II

Brand / firm

SenTec AG

Sold / distributed

US Nationwide distribution in the states of CA, FL, IL, MA, MS, MT, NV, and TX.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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