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
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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