GE Healthcare Recalls Airway Modules, Accessories
GE Healthcare, LLC has recently issued a Class I medical device recall for its single-width airway modules, accessories, and extension modules due to a risk of serious injury or death.
About the GE Healthcare Airway Module Recall
According to the U.S. Food and Drug Administration (FDA), these products could fail to properly detect C02 levels in patients on mechanical and spontaneous ventilators. If this happens, doctors may make decisions that can lead to serious injury or death based off of the incorrect C02 values. GE Healthcare says it is unaware of any injuries or deaths linked to the defect.
Description of the Recalled Airway Modules
- The single-width airway modules (E-miniC) have serial numbers that range from 6818561 through 6898777.
- The extension modules N-FC and N-FREC have serial numbers that range from 6799191 through 6905206.
- The serial number is located on the device plate attached to the module.
- The recalled devices were manufactured between Feb 10, 2012 and Oct 2, 2012, and distributed between Feb 2012 and April 2014.