Recalled GE Anesthesia Devices Labeled High-Risk by the FDA

WASHINGTON, D.C. — The website Med Tech Drive recently published information regarding the recall of General Electric Healthcare’s defective anesthesia systems that have been recalled by the company and the U.S. Food and Drug Administration (FDA). GE Healthcare reported that the recall program affects 3,600 anesthesia care stations. The devices have a loose cable that could potentially impede ventilation of the patient. If that happens, the patient could suffer low levels of oxygen. Low oxygen levels can cause organ damage and death.  The FDA considers the recall initiative to be a Class I recall. A Class I recall indicates that the defective medical device could cause serious injury or death to a patient if the device failed.

The FDA’s Class I designation of the GE Healthcare recall warns hospitals, surgical outpatient centers, and medical clinics across the country that these devices are potentially lethal. However, GE Healthcare circulated documentary guidance, indicating that the systems were safe to use. GE called attention to a message healthcare providers could see on the machine alerting them to ventilate the patient manually instead of relying upon the machine. An alarm should sound as well if the system fails and the attendants must ventilate the patient manually. Medical staff could switch over to a different anesthesia system if necessary. Furthermore, GE Healthcare advised clients to perform routine maintenance annually. Annual maintenance should help providers keep their devices running correctly and ensure the ventilation tube remains securely intact.

The recalled anesthesia systems were distributed and manufactured between August 2018 and July of 2019.

GE Healthcare announced another Class I recall about two weeks before the anesthesia system recall. The first recall announced by GE Healthcare in 2020 related to the brand’s Carescape respiratory modules. Those recalled devices failed to register critical readings of a patient’s oxygen saturation and carbon dioxide levels correctly.

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