Draeger Medical, Inc. Recall 87819
Description: Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Draeger Medical, Inc. Recall 87819 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1692-2021 |
| Event ID | 87819 |
| Event Description | Critical Care Ventilator, Catalog Number(s): 8422200: Babylog VN600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of PA, TX, MD, FL, TX, WA, MS, NY. |
| Quantity | 2 units |
| Recall Reason | Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning |
| Device Classification | 20210609 |
| Device Code Info | All lots/serial numbers manufactured from 1/1/2019-3/31201 |
| Center Classification Date | 20210528 |
| Recall Initiation Date | 20210416 |
| Recalling Firm | Draeger Medical, Inc. |
| Initial Notification | Letter |
| Similar To |