China NMPA Product Recall - X-ray computed tomography equipment, X-ray computed tomography equipment

Philips (China) Investment Co., Ltd. initiated a voluntary Level III recall for various X-ray Computed Tomography (CT) Equipment, including Ingenuity and Brilliance series, manufactured by Philips Medical Systems (Cleveland), Inc. This recall was reported on November 7, 2016, and publicly announced by the National Medical Products Administration (NMPA) on December 29, 2016. The core issue involves a potential mechanical connection failure that prevents the patient support bed from moving horizontally during a CT scan. A significant concern is the equipment's inability to automatically detect this malfunction, halt the scan, or alert the user, which could pose a safety risk. Although only two such failures were reported over ten years among 5000 potentially affected systems, the company is taking action under NMPA guidelines, referencing specific national medical device registration certificates. The required corrective action involves Philips' field engineers contacting affected customers globally, including 1152 units imported and sold in China, to issue Field Correction Orders (FCOs) to resolve the identified technical deficiency.