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Draeger Medical, Inc. Recall 89702

Description: 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. Recall 89702 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0871-2022
Event ID89702
Event DescriptionBabylog 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
Product TypeDevices
DistributionUS Nationwide
Quantity13,687 (2,987 units US)
Recall ReasonCybersecurity Improvement Action-not equipped against potential cyber security threats
Device Classification20220413
Device Code InfoAll Lots/Serial Numbers. UDI: 04048675250418
Center Classification Date20220404
Recall Initiation Date20220214
Recalling FirmDraeger Medical, Inc.
Initial Notification Letter
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