FDA Issues Recall Notice About Ge’s E-Minic Co2 Detectors

The FDA recently warned healthcare professionals of a recall of GE Healthcare E-miniC Airway Modules and accessories. These medical devices are used in “health care facilities for monitoring CO2 [carbon dioxide] and respiration rates in patients weighing over 11 pounds.” GE Healthcare has recalled modules with certain serial numbers because of a defect that could cause them to fail or provide incorrect CO2 levels. This, in turn, may negatively affect decision making by physicians, “lead[ing] to permanent, irreversible impairment or life-threatening changes in patients.” Possible complications may include “inadequate exchange of gases (hypoventilation)” and death due to low CO2 concentrations.

GE Healthcare has sent Urgent Medical Device Recall letter with safety instructions to its customers. The initiated recall is Class I – the most serious type of recall used when “there is a reasonable probability… [of] serious adverse health consequences or death.”

Sources:

• http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm406730.htm
• http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm406734.htm