Oct

2021

Recall – Inadvertent restart of ventilator

Company: Draeger Medical, Inc.
Date of Enforcement Report: 10/20/2021
Class II

PRODUCT

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

Catalog Number: 8416400

Recall Number: Z-0108-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

Draeger Medical, Inc. on 9/10/2021. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

6,797 units

DISTRIBUTION

U.S. Nationwide

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Recall – Inadvertent restart of ventilator

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