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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0109-2022 |
| Event ID | 88635 |
| Event 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 |
| Product Type | Devices |
| Distribution | US Nationwide |
| Quantity | 2,169 units |
| Recall Reason | Software 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 Classification | 20211020 |
| Device Code Info | Software 2.51 and Lower |
| Center Classification Date | 20211013 |
| Recall Initiation Date | 20210910 |
| Recalling Firm | Draeger Medical, Inc. |
| Initial Notification | Letter |
| Similar To |