China NMPA Product Recall - Medical Angiography X-ray System

Philips Medical Systems Nederland B.V. has initiated a voluntary Class II recall for its Medical Angiography X-ray System. This action, reported by the National Medical Products Administration (NMPA) on July 10, 2025, addresses a manufacturing defect: a possible insufficient torque on the bolts connecting the gearbox to the C-arm rolling motor mounting flange. This particular model, registered under National Medical Device Registration Certificate No. 20193060317, was not imported into China. The recall is a proactive measure by the company to mitigate potential safety risks associated with the identified issue. No specific inspection dates are relevant, as this is a company-initiated recall rather than a regulatory inspection finding. Details concerning specific models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." The NMPA's publication of this notice highlights its role in overseeing medical device safety and ensuring manufacturers address product deficiencies, even if the affected products are not distributed within China's domestic market. This voluntary recall demonstrates the company's commitment to product quality and patient safety.