# FDA recall Z-2441-2020

> **Mediana Co., Ltd.** · Class II · device recall initiated 2020-05-15.

## Product

DIRECT SUPPLY Attendant VITAL SIGNS MONITOR, REF AVSM2 - Product Usage: It is vital sign monitor 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

Failures were found in the temperature measurement function while in the predict mode.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2441-2020
- **Recalling firm:** Mediana Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-15
- **Report date:** 2020-07-08
- **Termination date:** 2022-09-16

- **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-2441-2020

## Citation

> AI Analytics. FDA recall Z-2441-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2441-2020. Source: US FDA. Licensed CC0.

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