FDA-Device2022-04-13Class II
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation 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
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Sold states
US Nationwide
Affected count
13,687 (2,987 units US)
Manufactured in
3135 Quarry Rd, Telford, PA, United States
Products
Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation 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-0871-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief