FDA slaps Class I tag on GE's ventilator recall

The FDA has assigned its most serious designation to GE Healthcare's ($GE) recall of Aestiva/5 7900, warning that a flaw in the devices could lead to circulatory shock and death.

GE launched a recall of the devices in April, warning that the two vaporizers in the continuous-breathing-support machines may malfunction and deliver agents at the same time. That could lead to the over-delivery of inhaled anesthetics, which the FDA said could lead to low blood pressure, irregular breathing, low heart rate and circulatory shock.

GE warned physicians of the issue on April 10 and has begun corrective action, but the FDA tabbed the recall a Class I because of the risk of fatal overdose from the ventilator's malfunction. 

The devices are used in hospitals and clinics to provide breathing support for patients undergoing surgery. The Aestiva/5 7900 has been on the market since 2000, but the affected models were manufactured in 2010, according to the FDA.

When last we heard from GE Healthcare, the company was taking a proactive approach to concerns about the effects of radiation exposure from its CT scanners, promising to work with hospitals to reduce radiation dosing by 50%.

- read the FDA notice
- get more from Reuters

Suggested Articles

Sherlock Biosciences teamed up with Cepheid to help develop its CRISPR-based molecular diagnostic tech in oncology, infections and the coronavirus.

The spine surgery company ATEC has moved to acquire Paris-based EOS imaging, makers of FDA-cleared scanners and 3D orthopedic planning software.

Digital molecule designer Insilico Medicine has launched a new preclinical research program focused on treatments for brain cancer.