FDA Medical Device Recalls (openFDA)
Viasys Respiratory Care, Inc.dba Bird Products: VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version)
- Recall number
- Z-0985-2008
- Recalling firm
- Viasys Respiratory Care, Inc.dba Bird Products
- Product
- VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version)
- Status
- Terminated
- Initiated
- 2007-12-17
- Posted
- 2008-05-14
- Terminated
- 2008-05-13
- Reason
- Alarm Failure -- There is a potential of alarms not being activated subsequent to specific electronic faults that may cause INOP condition.
- Root cause
- Component design/selection
- Action
- On December 18, 2007, a product notification letter was mailed to all customers in the United States via overnight carrier (registed mail) and a product notification letter was mailed to all international customers via Federal Express. The recall letter informed the customers of the problem and also inform them that a Cardinal Health (Viasys) service representative will be contacting them immediately to arrange & service their ventilator. For futher information please contack Andrea von Muller at 760-778-7323.
- Quantity
- 4
- Distribution
- Worldwide Distribution --- USA including states of AL, CA, MA, NM, NV, and NY and country of Italy.
- Lot, serial or model codes
- Catalog numbers: 17311-00; Serial numbers: AHV03000, AHV03001, AHV03004, AHV03005
- 510(k) numbers
- ["K013642","K022674","K062093"]
- 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