VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version)

FDA device recall Z-0982-2008 · posted 2008-05-14 · Terminated

Recall details

Recalling firm: Viasys Respiratory Care, Inc.dba Bird Products
Reason for recall: Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
Action taken: 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.
Root cause: Component design/selection
Status: Terminated
Product code: CBK
Quantity affected: 2
Distribution: Worldwide Distribution --- USA including states of AL, CA, MA, NM, NV, and NY and country of Italy.
Date initiated: 2007-12-17
Date posted: 2008-05-14
Date terminated: 2008-05-13
Location: Palm Springs, CA

Recalls and clearances share one API, with change alerts when new recalls post.