FDA: Class I recall of GE Healthcare CARESCAPE Respiratory Modules, Airway Gas Option

Editor's Note

The Food and Drug Administration (FDA) on February 4 identified the recall by GE Healthcare of its CARESCAPE Respiratory Modules and Airway Gas Option as Class I, the most serious.

The recall was initiated because of a manufacturing issue that may cause the devices to display incorrect oxygen values, which could lead to high or low blood oxygen levels in patients. Use of the affected equipment could result in organ damage, tissue injury, increased chance of infection, or death.

Manufacturing and distribution dates were June 7 to August 16, 2019. To date, there have been no reported injuries or deaths.