# FDA recall Z-1980-2023

> **SenTec AG** · Class II · device recall initiated 2023-05-02.

## 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

- **Recall number:** Z-1980-2023
- **Recalling firm:** SenTec AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-02
- **Report date:** 2023-06-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Therwil, Switzerland

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1980-2023. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-1980-2023. Source: US FDA. Licensed CC0.

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