FDA recall Z-1980-2023

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-05-02

Report date

2023-06-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Therwil, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1980-2023