GE Healthcare Recalls Respiratory Accessories

GE Healthcare has begun a Class 1 recall of its CareScape Respiratory Modules and Airway Gas Option due to a manufacturing issue which may cause the devices to display incorrect oxygen values. Incorrect oxygen values could lead to high (hyperoxia) or low (hypoxia) blood oxygen levels in patients, according to a recall notice. “The use of the affected product may cause long-term high or low blood oxygen levels, which could result in organ damage, tissue injury, increased chance of infection, or death,” it says. To date, there have been no reported injuries or deaths, it adds.

The Carescape Respiratory Modules and Airway Gas Option are respiratory accessories designed for use with patient monitors and ventilators to measure respiratory gases (oxygen and carbon dioxide), anesthesia, and breathing characteristics in adults, pediatric, and neonatal patients.