China NMPA Product Recall - Mobile O-arm X-ray machine O-arm O2 Imaging System

Medtronic Navigation, Inc. (Littleton), a medical device manufacturer, has initiated a voluntary Class II recall of its O-arm O2 Imaging System, known as mobile O-arm X-ray machines. This action was reported by Medtronic (Shanghai) Management Co., Ltd. to the National Medical Products Administration (NMPA) on June 11, 2025. The recall addresses a critical manufacturing issue involving potential damage to a mechanical component within a specific batch of these X-ray machines. This defect could cause intermittent jamming or unusual noise during operation, thereby compromising the device's integrity and reliability. The O-arm O2 Imaging System holds National Medical Device Registration Certificate No. 20183060139, issued under NMPA's regulatory framework. While this is a global recall, the NMPA document confirms that the particular batch of products involved was not imported into China. As a required action, Medtronic Navigation, Inc. is actively recalling the affected devices. Detailed information, including specific models, specifications, and batch numbers, is available in the accompanying "Medical Device Recall Event Report Form," highlighting the company's proactive approach to patient safety and product quality.