FDA recall Z-0108-2022

Draeger Medical, Inc. · Class II · device

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

Status: Ongoing
Initiation date: 2021-09-10
Report date: 2021-10-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Telford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0108-2022