China NMPA Product Recall - X-ray computed tomography (CT) system

Philips (China) Investment Co., Ltd., in collaboration with its manufacturer Philips Medical Systems (Cleveland), Inc., initiated a Class II voluntary recall of X-ray Computed Tomography (CT) systems, as reported by the National Medical Products Administration (NMPA) on November 18, 2015. The recall, detailed in an October 30, 2015 report, addresses a critical safety issue where the patient stent/scanning bed unexpectedly descended to its lowest point during examinations. This concern impacts 152 units in China, including models such as Brilliance CT 16 Slice, Brilliance CT 64, Brilliance Big Bore Oncology, Brilliance iCT, and Ingenuity CT. While no injuries have been reported, the potential for patient harm necessitated this action under NMPA's regulatory oversight. As required corrective actions, Philips issued a Field Safety Notification (FSN) to all affected users and is deploying Field Service Engineers and Field Operations Officers to replace the faulty vertical drive component on all identified systems, ensuring patient safety and operational integrity.