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Class 2 Device Recall Viasys Vela Adult/Pediatric Lung Ventilator |
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Date Initiated by Firm |
January 31, 2007 |
Date Posted |
March 20, 2007 |
Recall Status1 |
Terminated 3 on September 18, 2008 |
Recall Number |
Z-0638-2007 |
Recall Event ID |
37318 |
510(K)Number |
K032451
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Product Classification |
Ventilator - Product Code CBK
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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 CA 92262-8000
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For Additional Information Contact |
Andre von Muller 760-778-7323
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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.
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FDA Determined Cause 2 |
Other |
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
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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 and Original Applicant = BIRD PRODUCTS CORP.
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