# FDA recall Z-0237-2020

> **Mindray DS USA, Inc. dba Mindray North America** · Class II · device recall initiated 2019-10-01.

## Product

Rosie4 Vital Signs Monitor with NIBP valve assembly board, p/n 115-017679-00, containing software version 8.1.5 - Product Usage: The monitor is intended for monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP). Temperature (TEMP) and Carbon Dioxide (CO2) on adult, pediatric, and neonatal patients in professional healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians

## Reason for recall

NIBP valve assembly board subject to this recall includes enhancements that are not included in the current marketing clearance:1. Anti-motion feature  2. NIBP hose blockage identification function

## Distribution

US Nationwide distributions.

## Key facts

- **Recall number:** Z-0237-2020
- **Recalling firm:** Mindray DS USA, Inc. dba Mindray North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-01
- **Report date:** 2019-11-06
- **Termination date:** 2021-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0237-2020

## Citation

> AI Analytics. FDA recall Z-0237-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0237-2020. Source: US FDA. Licensed CC0.

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