China NMPA Product Recall - Digital medical X-ray imaging system

On March 31, 2021, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its Digital Medical X-ray Imaging Systems, as announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall addresses an identified issue where the Digital Diagnost system, specifically launched for the Chinese market, was inadvertently equipped with the incorrect vertical support model, BuckyDiagnost VS (VS1), instead of the intended VS2. This discrepancy, documented internally under recall number FCO71200203, necessitated corrective action. The affected products include specific models, specifications, and batches of the Digital Medical X-ray Imaging System, identifiable by Registration Certificate No.: 国械注进20182300006. While the immediate health impact is deemed low, leading to a Class III classification — indicating that the use of or exposure to the violative product is not likely to cause adverse health consequences — the recall underscores the company's commitment to product integrity and regulatory compliance. Philips (China) Investment Co., Ltd. is actively managing this recall under the regulatory framework of the NMPA, ensuring that all affected medical devices are identified and addressed. This proactive measure aims to rectify the component error and uphold the safety and performance standards of medical equipment within the Chinese market. Further detailed information regarding the precise scope of affected products is contained within the "Medical Device Recall Event Report Form" linked to the official announcement.