medical Class II Updated 2021-06-09

Draeger Medical, Inc. recalls Critical Care Ventilator, Catalog Number(s): 8422400: Babylo

Recalled Product

Critical Care Ventilator, Catalog Number(s): 8422400: Babylog VN800 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.

Hazard / Issue

Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots/serial numbers manufactured from 1/1/2019-3/31201
View official government recall

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