# FDA recall Z-1690-2021

> **Draeger Medical, Inc.** · Class II · device recall initiated 2021-04-16.

## Product

Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

## Reason for recall

Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800:  1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning

## Distribution

US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY.

## Key facts

- **Recall number:** Z-1690-2021
- **Recalling firm:** Draeger Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-16
- **Report date:** 2021-06-09
- **Termination date:** 2024-02-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Telford, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1690-2021

## Citation

> AI Analytics. FDA recall Z-1690-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1690-2021. Source: US FDA. Licensed CC0.

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