Date Initiated by Firm |
December 17, 2007 |
Date Posted |
May 14, 2008 |
Recall Status1 |
Terminated 3 on May 13, 2008 |
Recall Number |
Z-0984-2008 |
Recall Event ID |
46215 |
510(K)Number |
k022674 K013642 K062093
|
Product Classification |
Continuous Ventilator - Product Code CBK
|
Product |
VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version) |
Code Information |
Catalog numbers: 17310-00; Serial numbers: AHV03020, AHV03021, AHV03022, AHV03023, AHV03024, AHV03025 |
Recalling Firm/ Manufacturer |
Viasys Respiratory Care, Inc.dba Bird Products 1100 Bird Center Dr Palm Springs CA 92262-8000
|
For Additional Information Contact |
Andre von Muller 760-778-7323
|
Manufacturer Reason for Recall |
Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
|
FDA Determined Cause 2 |
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 in Commerce |
6 |
Distribution |
Worldwide Distribution --- USA including states of AL, CA, MA, NM, NV, and NY and country of Italy. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = CBK and Original Applicant = BIRD PRODUCTS CORP. 510(K)s with Product Code = CBK and Original Applicant = VIASYS RESPIRATORY CARE INC
|