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
Reported: October 20, 2021 Initiated: September 10, 2021 #Z-0109-2022
Product 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
Reason for Recall
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
Details
- Recalling Firm
- Draeger Medical, Inc.
- Units Affected
- 2,169 units
- Distribution
- US Nationwide
- Location
- Telford, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Draeger Medical, Inc.. Units affected: 2,169 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 20, 2021. Severity: Moderate. Recall number: Z-0109-2022.
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