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U.S. Department of Health and Human Services

Class 2 Device Recall AVEA Ventilator

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  Class 2 Device Recall AVEA Ventilator see related information
Date Initiated by Firm December 17, 2007
Date Posted May 14, 2008
Recall Status1 Terminated 3 on May 13, 2008
Recall Number Z-0986-2008
Recall Event ID 46215
510(K)Number k022674  K013642  K062093  
Product Classification Continuous Ventilator - Product Code CBK
Product VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version)
Code Information Catalog numbers: 17312-00; Serial numbers: AHV03066, AHV03040, AHV03041, AHV03042, AHV03043, AHV03044, AHV03045, AHV03046, AHV03047, AHV03049, AHV03095, AHV03096, AHV03097, AHV03098, AHV03099, AHV03100, AHV03101, AHV03102, AHV03103, AHV03104, AHV03105, AHV03106, AHV03121, AHV03123, AHV03124, AHV03129, AHV03134, AHV03136
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 28
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
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