Date Initiated by Firm | December 17, 2007 |
Date Posted | May 14, 2008 |
Recall Status1 |
Terminated 3 on May 13, 2008 |
Recall Number | Z-0985-2008 |
Recall Event ID |
46215 |
510(K)Number | K013642 K022674 K062093 |
Product Classification |
Continuous Ventilator - Product Code CBK
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Product | VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version) |
Code Information |
Catalog numbers: 17311-00; Serial numbers: AHV03000, AHV03001, AHV03004, AHV03005 |
Recalling Firm/ Manufacturer |
Viasys Respiratory Care, Inc.dba Bird Products 1100 Bird Center Dr Palm Springs CA 92262-8000
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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 | 4 |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = CBK 510(K)s with Product Code = CBK
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