VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
FDA Recall Z-0638-2007 · Posted 2007-03-20
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Recalling FirmViasys Respiratory Care, Inc.dba Bird Products
Recall StatusTerminated
Product CodeCBK
Date Initiated2007-01-31
Date Terminated2008-09-18
Product Quantity878
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.
Firm 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
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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