FDA Medical Device Recalls (openFDA)
Carefusion 211 Inc dba Carefusion: AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Recall number
- Z-1891-2016
- Recalling firm
- Carefusion 211 Inc dba Carefusion
- Product
- AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Status
- Terminated
- Initiated
- 2016-05-17
- Posted
- 2016-06-13
- Terminated
- 2017-09-28
- Reason
- CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
- Root cause
- Under Investigation by firm
- Action
- CareFusion sent a Field Safety Notice dated May 17, 2016, to all affected customers. The notice informed customers that CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM). This malfunction creates a blank AVEA Ventilator UIM and INOP condition during pre-use check or during use with cessation of ventilation to the patient. By design an audible clinical alarm is activated. Customers were informed of the problems identified and the actions to be taken. Customers were not required to return the affected devices or suspend use, customers would receive an copy of the identified affected serial numbers, as well as a response card, customers were requested to promptly return the response card to expedite the correction process and acknowledge receipt of the notification, Customers would be contacted by CareFusion to arrange onsite remediation of the affected devices, in the interim if any AVEA ventilator unit in their facility exhibits a blank AVEA Ventilator UIM and INOP condition during pre-use check or during use with cessation of ventilation, immediately remove the ventilator from service, provide alternate ventilation and contact CareFusion Technical Support per the contact information listed below to report the issue. Customers with questions should call 888-562-6016, for technical support 800-231-2466 or support.vent.us@carefusion.com.
- Quantity
- 922 units total (501 units in US)
- Distribution
- Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.
- Lot, serial or model codes
- n/a
- 510(k) numbers
- ["K013642","K073069","K103211"]
- PMA numbers
- not on file
- Product code
- CBK
- Firm FEI
- 3013421741
- Firm city
- Yorba Linda
- 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