Class I Recall for GE Respiratory Devices

Recall for GE Respiratory Devices

WASHINGTON, D.C. — General Electric Healthcare announced an urgent recall for its Carescape respiratory modules along with the company’s Airway Gas Option NCAiO units. GE Healthcare commenced the recall program in the fall of 2019 due to faulty oxygen sensors that misread the patient’s oxygen levels and display the incorrect readings. The dangers patients who are monitored by malfunctioning machines face include death, organ damage, tissue damage, and an increased risk of infection according to MassDevice.com. The U.S. Food and Drug Administration (FDA) related that there had been no reports of injuries or illness attributed to the malfunctioning devices to date.

The recall for eight GE Healthcare Carescape Devices is considered to be a Class I recall by the FDA. The FDA ranks recall programs in terms of urgency and possible threats to the public. A Class I designation signifies that the recall is urgent and that the devices might injure or kill someone if the item is not recalled. The devices subject to recall by GE Healthcare are reported to be B850, B650, and B450 Carescape patient monitors. The company also recalled its B40(i), B105, and B125 patient monitors. GE Healthcare recalled its Avance CS2, and also its Aisys CS2 anesthesia Carestations. Furthermore, GE Healthcare added its Carestation 620, 650, and 650c anesthesia models, its Carescape R860 critical care ventilators as well as its S/5 modular monitors to the recall list.

GE Healthcare said that its Airway Gas Option monitors compatible with the B40(i), B105, B125, Carestation 620, 650, and 650c devices are also subject to the Class I recall.

This recall is the second recall announced by GE Healthcare in two weeks. The FDA and GE Healthcare jointly announced that some of the brand’s telemetry devices and nursing station monitors were susceptible to cyber-attacks. The company recalled those devices and distributed an electronic patch to protect the modules.