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 |
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