China NMPA Product Recall - Mobile C-arm X-ray machine

Philips Medical Systems Netherlands AB, in cooperation with Philips (China) Investment Co., Ltd., has initiated a voluntary Class III recall for its mobile C-arm X-ray machines. This recall, formally reported to the National Medical Products Administration (NMPA) on October 21, 2025, addresses a critical product concern. The identified issue is the potential for corrosion on the control board of the Zenition 50 image intensifier (11W). This corrosion could lead to a loss of imaging function or compromised image quality, impacting diagnostic capabilities. The affected device is registered under National Medical Device Registration Certificate No. 20203060476. Philips has provided specific details regarding the involved models, specifications, and batches in a 'Medical Device Recall Event Report Form,' which is available as an attachment. This voluntary action highlights the company's commitment to product safety and compliance with NMPA regulations, ensuring that potential risks are addressed promptly.