China NMPA Product Recall - X-ray computed tomography equipment

Philips Medical (Suzhou) Co., Ltd. initiated a voluntary Class II recall for its X-ray Computed Tomography Equipment, specifically the Brilliance CT 16 model. This action, reported to the National Medical Products Administration (NMPA) on October 30, 2018, addresses a critical product safety concern impacting 52 units sold in China. The primary issue identified is the potential for the gantry front cover to separate from the main frame of the CT system, a defect traced to a specific supplier's component. In response to this safety risk, Philips Healthcare (Suzhou) Co., Ltd. has informed all affected users and issued Field Corrective Actions (FCOs), identified internally as FCO72800703/704. Philips' field engineers will directly contact impacted customers to perform necessary field updates and rectify the problem, ensuring the safe and proper functioning of these medical devices.