China NMPA Product Recall - Mobile C-arm X-ray system, mobile C-arm X-ray machine, medical angiography X-ray system

Philips Medical Systems Nederland B.V., in collaboration with its Chinese affiliate Philips (China) Investment Co., Ltd., has initiated a voluntary Class III recall of specific medical imaging equipment. This action was officially reported by the National Medical Products Administration (NMPA) on October 23, 2023. The recall targets several product categories, including mobile C-arm X-ray systems, mobile C-arm X-ray machines, and medical angiography X-ray systems. The primary reason for this recall stems from identified manufacturing deficiencies: certain devices lack crucial safety warning signs and appropriate patient entrance reference points. Such omissions are critical as they could potentially compromise patient safety, lead to improper device usage, or result in inaccurate positioning during medical procedures. While a comprehensive list of affected models, specifications, and batches is provided in an attached "Medical Device Recall Event Report Form," the scope includes devices registered under various National Medical Device Registration Certificates. This voluntary recall demonstrates Philips' proactive approach to addressing product non-conformities and upholding regulatory standards set by the NMPA, ensuring the integrity and safety of medical devices distributed within the market.