China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd., operating under the regulatory framework of the National Medical Products Administration (NMPA), initiated a voluntary Class III recall on July 8, 2016, for specific X-ray Computed Tomography (CT) equipment, including Ingenuity Corc 128 and Ingenuity Flex models. The core issue, a manufacturing defect, involves hydrogen embrittlement in fasteners used within these CT systems. This problem was traced to excessive hydrogen introduced during the electroplating process by one of Philips' suppliers. Hydrogen-embrittled fasteners carry a risk of breaking or failing under stress. Philips' evaluation concluded that despite this, sufficient safety margins prevent single-point failure, and the overall hazard was deemed virtually impossible, with no reported complaints, injuries, or deaths linked to the issue. Out of an abundance of caution, Philips Healthcare (Suzhou) Co., Ltd. committed to corrective actions. These include notifying users of affected products via a detailed letter and performing proactive field corrective action FC072800649 to replace the compromised locking fasteners on all impacted CT equipment globally, including 30 units sold in China. This demonstrates the company's adherence to regulatory standards and commitment to product safety.