Draeger Medical, Inc. Recall 89702
Description: Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Draeger Medical, Inc. Recall 89702 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0870-2022 |
Event ID | 89702 |
Event Description | Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400 |
Product Type | Devices |
Distribution | US Nationwide |
Quantity | 24,337 (10,728 units US) |
Recall Reason | Cybersecurity Improvement Action-not equipped against potential cyber security threats |
Device Classification | 20220413 |
Device Code Info | All Lots/Serial Numbers. UDI: 04048675042266 |
Center Classification Date | 20220404 |
Recall Initiation Date | 20220214 |
Recalling Firm | Draeger Medical, Inc. |
Initial Notification | Letter |
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