# FDA recall Z-2096-2021

> **Mediana Co., Ltd.** · Class II · device recall initiated 2021-05-17.

## Product

AVSM3 SNF, Vital Signs Monitor    The monitor is intended to be used to monitor noninvasive blood pressure (NIBP), functional arterial oxygen saturation (SpO2), pulse rate (PR), temperature (Temp) for adult, pediatric and neonatal patients in all areas of a hospital and hospital-type facilities.

## Reason for recall

In some cases the equipment fails to power up and/or key or button unresponsive or not working.

## Distribution

US Distribution to: Wisconsin only

## Key facts

- **Recall number:** Z-2096-2021
- **Recalling firm:** Mediana Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-05-17
- **Report date:** 2021-07-28
- **Termination date:** 2022-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wonju, N/A, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2096-2021

## Citation

> AI Analytics. FDA recall Z-2096-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2096-2021. Source: US FDA. Licensed CC0.

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