# FDA recall Z-0108-2022

> **Draeger Medical, Inc.** · Class II · device recall initiated 2021-09-10.

## Product

Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients.  Catalog Number: 8416400

## Reason for recall

Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur  and loss of PEEP for approx. 8 seconds

## Distribution

US Nationwide

## Key facts

- **Recall number:** Z-0108-2022
- **Recalling firm:** Draeger Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-09-10
- **Report date:** 2021-10-20

- **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-0108-2022

## Citation

> AI Analytics. FDA recall Z-0108-2022. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0108-2022. Source: US FDA. Licensed CC0.

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