Recall Z-0638-2007 ยท CBK Ventilator, Continuous, Facility Use
Viasys Respiratory Care, Inc.dba Bird Products
VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
| Date | Mar 20, 2007 (initiated Jan 31, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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, |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032451 | BIRD TBIRD VELA VENTILATOR Bird Products Corp., Mar 17, 2004 |