China NMPA Product Recall - X-ray computed tomography equipment

Philips Medical (Suzhou) Co., Ltd. initiated a voluntary Class II recall for 52 units of its X-ray Computed Tomography Equipment, specifically the Brilliance CT 16 model, distributed across China. This recall, formally reported to the National Medical Products Administration (NMPA) on October 30, 2018, addresses a significant product safety issue. The primary concern is the potential for the gantry front cover to detach from the equipment's main frame. Investigations revealed this issue stemmed from a manufacturing defect associated with a specific component supplier. Under the regulatory oversight of the NMPA, Philips Medical (Suzhou) Co., Ltd. has taken immediate corrective steps. The company proactively informed all affected customers about the defect and deployed specific Field Corrective Actions, identified as FCO72800703 and FCO72800704. These actions mandate that Philips' field engineers directly engage with customers to conduct essential on-site updates and repairs, thereby resolving the potential separation issue and restoring the equipment's integrity. This demonstrates the company's commitment to ensuring the safe and reliable operation of its advanced diagnostic imaging devices.