FDA Medical Device Recalls (openFDA)
Viasys Respiratory Care, Inc.dba Bird Products: VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
- Recall number
- Z-0638-2007
- Recalling firm
- Viasys Respiratory Care, Inc.dba Bird Products
- Product
- VIASYS VELA Ventilator, Catalog Number-16186; Viasys Respiratory Care, Inc.
- Status
- Terminated
- Initiated
- 2007-01-31
- Posted
- 2007-03-20
- Terminated
- 2008-09-18
- 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, 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
- 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.
- Lot, serial or model codes
- Lot numbers: AGT03640 thru AGT06049
- 510(k) numbers
- ["K032451"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 2021710
- Firm city
- Palm Springs
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28