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U.S. Department of Health and Human Services

Class 2 Device Recall Viasys Vela Adult/Pediatric Lung Ventilator

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 Class 2 Recall
Viasys Vela Adult/Pediatric Lung Ventilator
see related information
Date Posted March 20, 2007
Recall Status1 Terminated on September 18, 2008
Recall Number Z-0638-2007
Recall Event ID 37318
Premarket Notification
510(K) Number
K032451 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
Code Information Lot numbers: AGT03640 thru AGT06049
Recalling Firm/
Manufacturer
Viasys Respiratory Care, Inc.dba Bird Products
1100 Bird Center Dr
Palm Springs, California 92262-8000
For Additional Information Contact Andre von Muller
760-778-7323
Manufacturer Reason
for Recall
The graphical user interface may become slow in its response and in some cases non-responsive. Under some circumstances this situation may cause the ventilator to delay the annunciation of alarms.
Action On January 31, 2007, 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 January 31, 2007, a product notification kit (including a product notification letter, download software, download instruction sheets and installation verification fax-back sheets) were mailed to all international customers via register mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package. Domestic Consignees will have product corrected by VIASYS service personnel. Self address postage paid envelopes will be provided with notifications to aid in effectiveness checks.
Quantity in Commerce 878
Distribution Worldwide Distribution ---USA and countries of Bangladesh, Bosnia, Brazil, China, Czech Republic, Ecuador, Estonia, Finland, France, Guatemala, Hong Kong, India, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Morocco, Netherlands, Portugal, Russian Federation, Taiwan, Thailand, Turkey & Vietnam.
Total Product Life Cycle TPLC Device Report

 
1 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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