China NMPA Product Recall - Medical angiography X-ray machine

On April 15, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of specific medical angiography X-ray machines. This action was reported under National Medical Products Administration (NMPA) Index No. JGXX-2019-10244 and Shanghai Food and Drug Administration Medical Device Registration No. 2019-069. The recall addresses an operational issue identified during fluoroscopy examinations: if a user changes the field of view (FOV) between 30cm and 20cm while simultaneously releasing the fluoroscopy foot switch, the device may lose its X-ray imaging function. This malfunction can result in a system lockout, necessitating a system restart to restore full operation, which could disrupt medical procedures. In response to this potential performance issue, GE Healthcare Systems is voluntarily recalling the affected angiography X-ray machines (Registration Certificate No.: 20173306458). Detailed information regarding the models and batches subject to this recall is available in the associated Medical Device Recall Event Report Form, underscoring the company's commitment to product safety and regulatory compliance.