1. Medtech Insight

GE Healthcare Recalls Respiratory Monitors Over Display Issue

It’s the second time in a month that the FDA has taken action related to the safety of GE’s CARESCAPE product line

 
• By Elizabeth Orr

Some models of GE Healthcare’s CARESCAPE respiratory modules are being recalled because they may incorrectly display a patient’s blood oxygen level. The US FDA has labeled the action a high-risk class I recall.

detailed illustration of a compass with Recall text, eps10 vector

GE Healthcare is recalling some CARESCAPE respiratory modules because a “manufacturing issue” could lead the units to display inaccurate blood oxygen levels, the US Food and Drug Administration announced on 4 February.

The agency has deemed the action a class I recall, meaning it poses a relatively high risk of patient injury or death. However, no such adverse events have yet...

More from Recalls

More from Policy & Regulation