Device product
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
Z-0871-2022
Product summary
- Event
- Event 89702
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13,687 (2,987 units US)
- Official record key
device-enforcement:Z-0871-2022
Official wording
Reason: Cybersecurity Improvement Action-not equipped against potential cyber security threats
Code information: All Lots/Serial Numbers. UDI: 04048675250418
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Cybersecurity Improvement Action-not equipped against potential cyber security threats