GE Healthcare (NYSE:GE) is recalling certain Carestation anesthesia systems in the U.S. due to a problem that could halt patient ventilation, according to the FDA.
FDA labeled the recall as Class I, the most serious type of medical device recall.
The Carestation 620/650/650c A1 models may have a loose interior cable connection that could cause the mechanical ventilation to stop working, the agency said. The malfunction would trigger audio and visual alarms to alert the healthcare provider to switch to a different ventilation system or to manual ventilation. Failure to do so could lead to low (hypoxia) blood oxygen levels in the patient, which could result in tissue or organ damage or death, according to the FDA.
The U.S. recall covers 3,599 units manufactured between August 2018 and July 2019. GE Healthcare began the recall in November. No injuries or deaths have been reported, the agency said.
News of the Class I designation for the Carestation recall comes only days after FDA designated a recall of certain GE Healthcare respiratory analyzers as serious. Certain Carescape respiratory modules and Airway Gas Option NCAiO units have faulty oxygen sensors that may cause them to display incorrect patient oxygen levels, according to the agency.