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

Philips Medical Systems Nederland B.V. has initiated a voluntary Class II recall for its Mobile C-arm X-ray Equipment due to identified manufacturing problems. This action was reported to the National Medical Products Administration (NMPA) by Philips (China) Investment Co., Ltd. on August 29, 2025. A Class II recall signifies a situation where the use of or exposure to the affected product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The specific models, specifications, and batches subject to this recall are detailed in a supplementary Medical Device Recall Event Report Form. It is important to note that the products involved in this recall were not imported into the Chinese market, thereby limiting direct impact within China. This proactive measure by Philips, under the regulatory framework of the NMPA, underscores the company's commitment to addressing product deficiencies and ensuring device safety and quality globally, even for products not distributed in certain regions.