Recall Z-0870-2022 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
| Date | Feb 14, 2022 |
| Status | Terminated |
| Reason | Cybersecurity Improvement Action-not equipped against potential cyber security threats |
| Root cause | Nonconforming Material/Component |
| Action | Draeger issued "Urgent Medical Device Correction Notices" on 2/14/22 to the Director, Clinical Engineering and Risk Manager via FedEx with tracking/confirmation of delivery. Letter states reason for recall, health risk and action to take: Continue to follow the recommendations in the instructions for use: o Limit or control physical access to the abovementioned ventilators. o Do not connect any non-approved devices to the USB, LAN and DVI interfaces. o Be attentive to notifications, alarms, and alerts Consider closing/covering all unused USB, LAN and DVI interfaces Should you decide to clo |
| Quantity | 24,337 (10,728 units US) |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093633 | INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE Draegerwerk AG & CO Kgaa, Mar 30, 2010 |