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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 Device Recall Viasys Vela Adult/Pediatric Lung Ventilatorsee related information
Date Initiated by FirmJanuary 31, 2007
Date PostedMarch 20, 2007
Recall Status1 Terminated 3 on September 18, 2008
Recall NumberZ-0638-2007
Recall Event ID 37318
510(K)NumberK032451 
Product Classification Ventilator - Product Code CBK
ProductVIASYS 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 CA 92262-8000
For Additional Information ContactAndre 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.
FDA Determined
Cause 2		Other
ActionOn 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 Commerce878
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = CBK
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