Draeger Medical, Inc. recalls Babylog VN500 Ventilator with Installed CO2 Measurement Option-intended for the ventilation of neonatal patients from 0.

Recalled October 20, 2021 · FDA recall Z-0109-2022 · Draeger Medical

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 · FDA Class II

Units

2,169 units

Sold at

US Nationwide

Description

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

Product

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

Manufacturer(s)

Draeger Medical, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →