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Draeger Medical, Inc. Recall 88635

Description: 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. Recall 88635 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0109-2022
Event ID88635
Event DescriptionBabylog 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
Product TypeDevices
DistributionUS Nationwide
Quantity2,169 units
Recall ReasonSoftware 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
Device Classification20211020
Device Code InfoSoftware 2.51 and Lower
Center Classification Date20211013
Recall Initiation Date20210910
Recalling FirmDraeger Medical, Inc.
Initial Notification Letter
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