China NMPA Product Recall - Fully digital remote-controlled fluoroscopic imaging system; remote-controlled X-ray gastrointestinal system

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall on April 29, 2019, for its fully digital remote-controlled fluoroscopy imaging systems and remote-controlled X-ray gastrointestinal systems. This action was prompted by a critical safety concern where product aging could cause the monitor to detach from its wall mount, posing a potential hazard. The recall notice, issued by the National Medical Products Administration (NMPA), highlighted the voluntary nature of GE Healthcare's response to the identified product defect, with the Shanghai Food and Drug Administration also referenced as part of the regulatory oversight. Affected product models and batch numbers are detailed in the accompanying "Medical Device Recall Event Report Form." This proactive measure by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. underscores the company's commitment to patient safety and adherence to medical device regulations under the NMPA's framework. The Level II classification indicates a situation where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. The company is taking steps to address the identified aging-related issue to prevent any potential risks to users and patients.