FDA-Device2021-10-20Class II
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Draeger Medical, Inc.
Hazard
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
Sold states
US Nationwide
Affected count
6,797 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0108-2022Don't want to check this manually?
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