FDA issues early alert for GE HealthCare’s infant resuscitation systems

The alert relates to a potential issue with certain blenders that mix air and oxygen to deliver controlled oxygen concentration. The alert relates to a potential issue with certain blenders that mix air and oxygen to deliver controlled oxygen concentration. GE HealthCare’s Giraffe and Panda product range were previously hit with a Class I recall from the FDA in 2019 due to side panel and latch assembly issues. Credit: jackpress / Shutterstock.com The US Food and Drug Administration (FDA) has issued an early alert over a ‘potentially high-risk’ device issue with certain GE HealthCare infant resuscitation systems and warmers. The…

Source: Medical Device Network