Medical device manufacturer CareFusion is recalling the AVEA ventilators due to a defect that may cause ventilators to unexpectedly shut down. A faulty fuse in the alarm board could cause the machine to turn off without a warning alarm. Ventilator shut-down can lead to serious health consequences or death.
CareFusion sent letters on May 17, 2016 to notify buyers of the defective ventilators about the defect and provide instructions for returning the ventilator.
Recalled products include:
AVEA Standard with Compressor ventilator-refurbished
AVEA Comprehensive Ventilator
AVEA Standard Ventilator
AVEA Standard with Compressor Ventilator
AVEA Comprehensive Ventilator-Refurbished
AVEA Standard Ventilator-Refurbished
AVEA Standard with Compressor Ventilator-Refurbished
GDE – 1st Generation
GDE – Refurbished
AVEA GDE/UIM Upgrade Kit
For more information, visit the FDA recall page.