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

Philips (China) Investment Co., Ltd., on behalf of Philips Medical Systems (Cleveland) Inc., initiated a voluntary Class II recall for specific X-ray Computed Tomography (CT) equipment in December 2014. This action was reported to the National Medical Products Administration (NMPA) in China, specifically the Shanghai Municipal Food and Drug Administration, on November 21, 2014, with the official publication date being December 12, 2014. The recall was prompted by the discovery that the scan length of certain Brilliance ICT and Brilliance ICT SP models (specifically Model 728306 and 728311) may deviate from the user's specified settings. This discrepancy poses a significant safety concern as it could lead to accidental radiation exposure for patients undergoing routine head and whole-body CT imaging. To address this critical issue, Philips committed to a corrective action plan. The company will issue direct field safety notices to inform affected users about the potential problem. Furthermore, field service engineers will contact all identified customers to schedule and perform necessary software upgrades on the affected CT systems, thereby resolving the potential for incorrect scan lengths and mitigating patient risk.