China NMPA Product Recall - Mobile O-arm X-ray machine

Medtronic Navigation, Inc. (Littleton), supported by Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class III recall for its mobile O-arm X-ray machines. This action, announced by the National Medical Products Administration (NMPA) on May 24, 2024, addresses a potential operational issue affecting the medical devices. The recall is prompted by the discovery of a possible intermittent shutdown of an electrical component within the imaging system, which could impede the system's intended operation. The affected products are identifiable by National Medical Device Registration Certificate No. 20183060139.A Class III recall signifies that while the issue is unlikely to cause serious adverse health consequences, it warrants attention to prevent operational disruptions. Medtronic has taken this step proactively to maintain product integrity and ensure user safety. Detailed information concerning the specific models, specifications, and batches of the mobile O-arm X-ray machines subject to this recall is provided in the accompanying "Medical Device Recall Event Report Form." Healthcare providers and facilities utilizing these devices are advised to review this report for comprehensive instructions on identifying affected units and implementing necessary actions to resolve the issue.