Recall Z-0984-2008 ยท CBK Ventilator, Continuous, Facility Use
Viasys Respiratory Care, Inc.dba Bird Products
VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version)
| Date | May 14, 2008 (initiated Dec 17, 2007) |
| Status | Terminated |
| Reason | Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition. |
| Root cause | Component design/selection |
| Action | On December 18, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (registed mail) and a product notification letter was mailed to all international customers via Federal Express. The recall letter informed the customers of the problem and also inform them that a Cardinal Health (Viasys) service representative will be contacting them immediately to arrange & service their ventilator. For futher information please contack Andrea von Muller at 760-778-7323. |
| Quantity | 6 |
| Distribution | Worldwide Distribution --- USA including states of AL, CA, MA, NM, NV, and NY and country of Italy. |
| FDA record | Open on fda.gov |