GE Healthcare, LLC, of Waukesha, WI has issued a recall of certain models of the company’s single-width airway modules and accessories used in hospitals and other healthcare facilities for monitoring CO2 and respiration rates in patients.
According to the company, the recalled CO2 detectors may fail to provide or provide incorrect CO2 values for patients who have been ventilated. As a result, healthcare workers may make critical decisions based on incorrect information, leading to potentially life-threatening changes to patient health, as well as permanent, irreversible impairment.
This recall has been categorized by the U.S. Food and Drug Administration (FDA) as a Class 1 recall, the most serious type of recall in which there is a reasonable probability that the use of a product will cause serious adverse health consequences or death.
