China NMPA Product Recall - X-ray computed tomography (CT) equipment, Ingenuity CT, Brilliance 64

Philips (China) Investment Co., Ltd., representing Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class II recall for its X-ray Computed Tomography (CT) equipment, specifically Ingenuity CT and Brilliance 64 models. The recall, reported to the National Medical Products Administration (NMPA) on September 8, 2016, and publicly announced on December 7, 2016, addressed a critical image quality degradation issue. During high-resolution head scans, the reconstructed images could exhibit non-uniformity, CT value shifts exceeding 5 Henle units, and reduced differentiation between gray and white matter. This problem was most severe in high-resolution mode, which was the default setting for Philips' factory reference pediatric scanning protocols. No patient injuries have been reported globally due to this issue. As required actions, Philips is undertaking Field Corrective Actions (FCOs) through software upgrades. Philips field engineers will contact all affected customers to schedule and implement the necessary software updates to resolve the image quality deficiencies on the 118 affected units worldwide, including 117 units sold in China.