Evita 4 Continuous Ventilator
FDA device recall Z-0954-03 · posted 2003-06-27 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- software problems - ventilation mode changes without user input, settings change without corresponding display change, false auto-set alarm.
- Action taken
- The recalling firm issued recall letters to the accounts dated 5/7/03.
- Root cause
- Other
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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.
- Date initiated
- 2003-05-07
- Date posted
- 2003-06-27
- Date terminated
- 2006-01-20
- Location
- Telford, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474 (K010093) | Drager Medizintechnik GmbH | 2001-06-14 |