Device product
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Z-0870-2022
Product summary
- Event
- Event 89702
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24,337 (10,728 units US)
- Official record key
device-enforcement:Z-0870-2022
Official wording
Reason: Cybersecurity Improvement Action-not equipped against potential cyber security threats
Code information: All Lots/Serial Numbers. UDI: 04048675042266
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Cybersecurity Improvement Action-not equipped against potential cyber security threats