Z-1894-2016 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 22, 2016
- Initiation Date
- May 17, 2016
- Termination Date
- September 28, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 922 units total (501 units in US)
Product Description
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Reason for Recall
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).
Distribution Pattern
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.