Z-0870-2022 Class II Terminated
FDA device recall Z-0870-2022 was initiated by Draeger Medical, Inc. on Feb 14, 2022 and is designated Class II. Reason for recall: Cybersecurity Improvement Action-not equipped against potential cyber security threats The recall status is terminated (terminated Jan 7, 2025). Affected quantity: 24,337 (10,728 units US).
Recall Details
- Product Type
- Devices
- Report Date
- Apr 13, 2022
- Initiation Date
- Feb 14, 2022
- Termination Date
- Jan 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0870-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026