Recall Z-0954-03 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Evita 4 Continuous Ventilator
| Date | Jun 27, 2003 (initiated May 7, 2003) |
| Status | Terminated |
| Reason | software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm. |
| Root cause | Other |
| Action | The recalling firm issued recall letters to the accounts dated 5/7/03. |
| Quantity | 806 units |
| Distribution | The product was shipped nationwide to distributor, hospitals and a physician. The product was also shipped to medical facilities and universities in Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010093 | NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 Drager Medizintechnik GmbH, Jun 14, 2001 |