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U.S. Department of Health and Human Services

Class 2 Device Recall V.I.P Sterling

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  Class 2 Device Recall V.I.P Sterling see related information
Date Initiated by Firm October 20, 2006
Date Posted January 11, 2007
Recall Status1 Terminated 3 on September 03, 2008
Recall Number Z-0481-2007
Recall Event ID 36740
510(K)Number K993449  
Product Classification pediatric ventilator - Product Code CBK
Product Viasys V.I.P. Bird Sterling pediatric ventilator, Catalog Number 15654
Code Information Serial numbers: AAM01128 to ABMO1015 for Domestic Customers and AAM01119 to ACMO1142 for International Customers
Recalling Firm/
Manufacturer		 Viasys Respiratory Care, Inc.
1100 Bird Center Dr
Palm Springs CA 92262-8000
For Additional Information Contact Andre von Muller
760-778-7323
Manufacturer Reason
for Recall		 The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
FDA Determined
Cause 2		 Other
Action On November 2, 2006, a product notification letter was mailed to all customers in the United States via overnight carrier (Federal Express). Consignees are informed in the notification letter that service calls are in process of being scheduled to update domestic consignees. On November 4, 2006, a product notification letter was mailed to all international customers via registed mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package.
Quantity in Commerce 539
Distribution Worldwide including USA, Canada, Estonia, Belgium, Saudi Arabia, Brazil, Thailand, United Arab Emirates, Syria, Portugal, Jordan, Italy, Latvia, Hong Kong China, Ecuador, Jamaica, Dominican Republic, New Zealand, Australia, Czech Republic, Bolivia, Austria, Greece, United Kingdom (England), Turkey, Chile, Japan, India, Mexico, Uruguay, Algeria, Vietnam, Costa Rica, Ireland, Switzerland, Bahamas, Singapore, South Africa, Philippines, Spain, France, Peru, Lebanon, Taipei, Malaysia, Netherlands, South Korea, Israel & Slovak Republic
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.
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