Draeger Medical, Inc. Recall 88635
Description: Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Draeger Medical, Inc. Recall 88635 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0108-2022 |
| Event ID | 88635 |
| Event Description | Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400 |
| Product Type | Devices |
| Distribution | US Nationwide |
| Quantity | 6,797 units |
| Recall Reason | Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds |
| Device Classification | 20211020 |
| Device Code Info | Software 2.51 and Lower |
| Center Classification Date | 20211013 |
| Recall Initiation Date | 20210910 |
| Recalling Firm | Draeger Medical, Inc. |
| Initial Notification | Letter |
| Similar To |