The U.S. Food and Drug Administration (FDA) has announced a Class I recall for thousands of GE mechanical ventilation systems, due to a defect that may cause the medical devices to fail unexpectedly, increasing the risk of serious injury or death among patients. The GE ventilator recall was announced on February 7 and affects 3,599 Carestation 600 series anesthesia systems manufactured by GE Healthcare, including model numbers 620, 650, 650c, A1 with the following serial numbers: 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, 1012-9655-002.
The recalled ventilation systems were manufactured by GE Healthcare between August 2018 and July 2019 and distributed to hospitals, surgical centers and healthcare facilities throughout the United States. According to the FDA, the ventilators may have a loose cable connection, which could cause the mechanical ventilation feature to stop working unexpectedly. “Loss of mechanical ventilation could lead to low (hypoxia) blood oxygen levels in the patient if the health care provider does not ventilate the patient manually or with an alternate system,” the FDA warns.
GE’s Healthcare’s Carestation 600 series anesthesia systems are used to provide general inhalation anesthesia and mechanical ventilation (breathing support) to adult and pediatric patients in hospitals, surgical centers and healthcare clinics nationwide. The GE ventilator recall was initiated in November 2019, when GE Healthcare first sent a letter to customers notifying them about the problem with the Carestation 600 series ventilation systems. At that time, GE indicated that customers should continue using the ventilators and that a GE representative would be contacting them to inspect and correct the faulty systems.
Class I recalls are the most serious type of recall, reserved for products or medical devices with faulty parts or defects that may cause serious injuries or death. According to the FDA’s recall announcement, the use of the recalled GE ventilators “may cause the patient to have low blood oxygen levels, which could result in tissue or organ damage, or death.” The recall has the potential to affect patients in healthcare facilities across the country who are receiving breathing support or mechanical ventilation with GE Healthcare’s Carestation 600 series anesthesia systems.
The GE ventilation system recall was issued just days after another Class I recall of Carescape Respiratory Modules manufactured by GE Healthcare. The recalled devices are meant to be used with patient monitors and ventilators to measure respiratory gases (oxygen and carbon dioxide), anesthesia and breathing characteristics in patients. The GE respiratory modules were recalled because of a manufacturing defect that may cause the devices to display incorrect oxygen values. According to the FDA, this problem could lead to high or low blood oxygen levels, “which could result in organ damage, tissue injury, increased chance of infection, or death” in patients receiving treatment with the GE Healthcare Carescape Respiratory Modules and Airway Gas Option monitoring equipment.