Home / Recalls / Medical Devices
Draeger Medical, Inc. recalls Babylog VN500 Ventilator with Software 2.51.01 and Lower- intended for the ventilation neonatal patients from 0.4 kg (0.
Recalled April 13, 2022 · FDA recall Z-0871-2022 · Draeger Medical
Hazard
Cybersecurity Improvement Action-not equipped against potential cyber security threats · FDA Class II
Units
13,687 (2,987 units US)
Sold at
US Nationwide
Description
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Product
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
Manufacturer(s)
Draeger Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →