Recall Z-0109-2022 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
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
| Date | Sep 10, 2021 |
| Status | Open, Classified |
| 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 |
| Root cause | Software design |
| Action | Drager issued Urgent Medical Device Recall letter on 9/10/21 via FedEx with tracking (confirmation of delivery). Letter states reason for recall, health risk and action to take: The release of a corrected software is expected to be available in Q4 of 2021. Once the software is available, your local Drger Service representative will contact you to arrange a date for the software update to be performed free of charge. According to our records, at least one of the mentioned affected devices has been shipped to your facility. Please ensure that all users of the above-mentioned products and other |
| Quantity | 2,169 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093632 | INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE Drager Medical AG & Co. Kgaa, Apr 5, 2010 |