Recall Z-2325-2008 ยท CBK Ventilator, Continuous, Facility Use
Draeger Medical, Inc.
Evita 2 dura Critical Care Ventilator. Continuous (Respirator)
| Date | Sep 20, 2008 (initiated Jul 2, 2008) |
| Status | Terminated |
| Reason | Audible power failure alarm was not enunciated at the required volume |
| Root cause | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 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. |
| 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 |