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

Philips (China) Investment Co., Ltd., in coordination with its manufacturer Philips Medical Systems (Cleveland), Inc., initiated a voluntary Class III recall for specific X-ray Computed Tomography (CT) Systems. This action, reported to the National Medical Products Administration (NMPA) on November 17, 2015, and published December 15, 2015, addresses a critical software anomaly. The primary issue involves certain CT scans unexpectedly extending the Z-axis scan length beyond the user's defined plan. This error is contingent on three specific conditions: the use of dual Surview (panoramic scan), a request for sagittal or coronal reconstruction, and a tilted gantry. While the potential for this deviation exists, Philips has confirmed no patient injuries have been reported globally due to this issue. The recall impacts models such as Brilliance 64 and Ingenuity CT systems, affecting 78 units globally, with 57 units sold in China. Operating under the NMPA's regulatory guidance, Philips has implemented a Field Corrective Action (FCO reference FC072800642). The required actions involve Philips notifying all affected users and deploying field engineers to conduct essential software upgrades on the identified systems to ensure proper functionality and patient safety.