FDA-Device2021-10-20Class II
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
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
2,169 units
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Products
Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.4 kg (0.88 lbs) up to 10 kg (22 lbs) and pediatric patients from 5 kg (11 lbs) up to 20 kg (44 lbs) bodyweight. Catalog Number: 8417400
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2022Don't want to check this manually?
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