Evita XL Critical Care Ventilator. Continuous (Respirator)
FDA device recall Z-2327-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- audible power failure alarm was not enunciated at the required volume
- Action taken
- The recalling firm issued an URGENT MEDICAL DEVICE RECALL letter dated 7/2/08 informing the consignees of the problem and the need to have the circuit board replaced.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 83 units
- Distribution
- The products were shipped to medical facilities in AZ, CA, CO, FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and WA.
- Date initiated
- 2008-07-02
- Date posted
- 2008-09-20
- Date terminated
- 2009-09-01
- 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 |
|---|---|---|
| EVITAXL WITH OPTION SMARTCARE (K051263) | Drager Medical AG & Co. Kgaa | 2005-07-12 |