Z-0870-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 13, 2022
- Initiation Date
- February 14, 2022
- Termination Date
- January 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,337 (10,728 units US)
Product Description
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Reason for Recall
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Distribution Pattern
US Nationwide
Code Information
All Lots/Serial Numbers. UDI: 04048675042266