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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0871-2022 |
Event ID | 89702 |
Event 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 |
Product Type | Devices |
Distribution | US Nationwide |
Quantity | 13,687 (2,987 units US) |
Recall Reason | Cybersecurity Improvement Action-not equipped against potential cyber security threats |
Device Classification | 20220413 |
Device Code Info | All Lots/Serial Numbers. UDI: 04048675250418 |
Center Classification Date | 20220404 |
Recall Initiation Date | 20220214 |
Recalling Firm | Draeger Medical, Inc. |
Initial Notification | Letter |
Similar To |