On October 10, the FDA announced a Class 1 recall of CareFusion’s EnVE and ReVEL ventilators, related to possible power connection failure.
According to the agency, “there is a potential for damage to their power cord adaptors which can cause loss of power and complete shut off. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly.”
The recalled ventilators were manufactured from May 2009 to August 2014 and distributed from December 10, 2010 to August 6, 2014. According to the agency, CareFusion notified customers of the recall on August 8, 2014. In the notification letter, the company stated that two new power adaptor accessory kits for the ReVel and EnVe ventilators would be sent to correct the problem.
For more detail, refer to the online Recall Notice on the FDA website.