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
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.
You may also be interested in...
US regulators and GE have notified health-care providers that the company’s nurse bay monitoring stations could be attacked by malicious hackers to turn off critical alarms that are intended to alert caregivers when a patient is in a critical state.
The US FDA has announced a high-risk class I recall on two makes of coronary dilation catheters made by Abbott Vascular because a manufacturing issue could lead to difficulties deflating the balloon. The catheters have been linked to 13 complaints and one death.
Medtronic’s MiniMed 600 series of insulin pumps is the subject of a high-risk class I recall because a component may break, leading to over- or under-dosing of insulin. The company warned patients of the issue last November.