FDA Medical Device Recalls (openFDA)
Viasys Respiratory Care, Inc.: Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653
- Recall number
- Z-0480-2007
- Recalling firm
- Viasys Respiratory Care, Inc.
- Product
- Viasys V.I.P. Bird Gold pediatric ventilator, Catalog Number 15653
- Status
- Terminated
- Initiated
- 2006-10-20
- Posted
- 2007-01-11
- Terminated
- 2008-09-03
- Reason
- The reason for this correction is due to the potential of a repeat ''failure to cycle'' event.
- Root cause
- Other
- Action
- On November 2, 2006, 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 November 4, 2006, a product notification letter was mailed to all international customers via registed mail. Consignees are informed in the notification letter that replacement software, replacement instructions, and installation verification forms are included in their recall package.
- Quantity
- 1478
- Distribution
- Worldwide including USA, Canada, Estonia, Belgium, Saudi Arabia, Brazil, Thailand, United Arab Emirates, Syria, Portugal, Jordan, Italy, Latvia, Hong Kong China, Ecuador, Jamaica, Dominican Republic, New Zealand, Australia, Czech Republic, Bolivia, Austria, Greece, United Kingdom (England), Turkey, Chile, Japan, India, Mexico, Uruguay, Algeria, Vietnam, Costa Rica, Ireland, Switzerland, Bahamas, Singapore, South Africa, Philippines, Spain, France, Peru, Lebanon, Taipei, Malaysia, Netherlands, South Korea, Israel & Slovak Republic
- Lot, serial or model codes
- Serial numbers: AAM01001 to AMMO1590 + KJI01178 for Domestic Customers and AAMO1648 to AEM01298 for International Customers
- 510(k) numbers
- ["K993449"]
- 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