China NMPA Product Recall - X-ray computed tomography equipment

Philips Medical Systems (Cleveland), Inc., in conjunction with its agent Philips (China) Investment Co., Ltd., initiated a voluntary Class III recall of its X-ray Computed Tomography Equipment, specifically the Brilliance CT Big Bore model. The recall, reported to the National Medical Products Administration (NMPA) of China on July 10, 2017, was prompted by a torque wrench calibration test failure. This failure could lead to incorrect torque settings for the X-ray tube installation fasteners, posing a potential issue for the equipment's functionality and safety. Despite this potential manufacturing defect, the regulatory submission confirmed that no affected batches or products were sold or distributed within China. Consequently, while the company proactively reported the issue under the NMPA's framework, no specific corrective actions were required from end-users or healthcare facilities in China, as the sales quantity of affected units in the region was zero. This recall highlights the company's commitment to product quality and regulatory compliance, even for potential issues not impacting the local market.