# FDA recall Z-1134-2021

> **SenTec AG** · Class II · device recall initiated 2020-12-10.

## Product

SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor indicated for continuous, noninvasive patient monitoring of carbon dioxide partial pressure (PCo2), oxygen partial pressure (POs), functional oxygen saturation (PsO2), and pulse rate (PR), using either a single digital sensor (V-Sign Sensor 2 or OxiVenT sensor).

## Reason for recall

Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

## Distribution

IL, PA, FL, NJ, GA, MA

## Key facts

- **Recall number:** Z-1134-2021
- **Recalling firm:** SenTec AG
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-12-10
- **Report date:** 2021-02-24

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1134-2021

## Citation

> AI Analytics. FDA recall Z-1134-2021. Retrieved 2026-09-26 from https://api.ai-analytics.org/recall/Z-1134-2021. Source: US FDA. Licensed CC0.

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