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