A Class I recall has been issued for several thousand GE mechanical ventilation systems, which may contain a defect that causes the devices to stop working unexpectedly, increasing the risk of organ injury or death to patients.
The FDA announced a GE Carestation 600 series anesthesia systems recall on February 7, because the cabling connection inside the device may come loose, causing the mechanical ventilation to stop working.
The GE Carestation 600 series devices are used in hospitals, surgical centers and clinics to provide general inhalation anesthesia and breathing support to pediatric and adult patients. The mechanical ventilators are critical for continued breathing support and surgical procedures where patients must undergo anesthesia.
In the event of a loose cable connection inside the system, loss of mechanical ventilation could occur, the recall notice warns. Patients requiring breathing support could suffer from low blood oxygen levels, resulting in tissue or organ damage, or death.
GE Healthcare issued a medical device warning on November 25, 2019, indicating that in the event of a loss of power scenario, the device will emit a high priority audio and visual alarm to alert the health care provider. A message on the display screen will read “Ventilate manually”. Healthcare providers should immediately switch the device from mechanical ventilation to manual ventilation or switch to another anesthesia system, the company warned.
The recall involves approximately 3,599 GE Carestation 600 series anesthesia systems with model numbers 620, 650, 650c, A1 and serial numbers 1012-9620-000, 1012-9620-002, 1012-9650-000, 1012-9650-002, 1012-9655-000, 1012-9655-002.
The impacted devices were manufactured by GE Healthcare Manufacturing Co. from August 2018 through July 2019, and were distributed to hospitals surgical centers and clinics throughout the United States.
The FDA has classified the recall with a Class I status, indicating it is the most serious type of recall and continued use of the device poses a reasonable probability of serious adverse health consequences or death. To date, no injuries or deaths have been reported in connection with the problem.
GE Healthcare indicated customers may continue to use the devices, but a representative will contact them to schedule an inspection and correct the affected systems. Customers with additional questions or concerns regarding the recall should contact GE Healthcare Customer Service at 1-800-437-1171.
The recall came just days after GE Healthcare issued another Class I recall of certain CARESCAPE Respiratory Modules on February 4, due to a manufacturing defect that may cause the devices to display incorrect oxygen values, leading to high or low blood oxygen levels in the patient.
According to that recall, a defect in the design of the monitoring devices could calculate and display incorrect oxygen values, causing long-term high or low blood oxygen levels. The agency warns these incidents could result in serious adverse health consequences for patients including organ damage, tissue injury, increased chance of infection, or death.
The recall included Airway Gas Option N-CAiO, and CARESCAPE Respiratory Modules with model numbers E-sCO, sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOE, and E-sCAiOVE. The devices were manufactured by GE Healthcare of Chicago, Illinois from June 7, 2019 through August 16, 2019 and were distributed for sale to healthcare facilities across the United States.