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 |
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