China NMPA Product Recall - Angiography X-ray system, medical angiography X-ray system

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for its Angiography X-ray Systems and Medical Angiography X-ray Systems, with the recall details published on May 8, 2017. The company discovered a potential problem within the detector cooling system of these devices, primarily identified through customer complaints. This issue necessitated a recall to address the potential malfunction. Operating under the regulatory oversight of the National Medical Products Administration (NMPA), Philips made the decision to retrieve the affected products from the market. While specific inspection dates are not provided in the document, the recall itself serves as a corrective action in response to product performance concerns. The required action involves the recall of all relevant product models and grades. Comprehensive information, including the specific product details, is available in the associated Medical Device Recall Event Report Form. This action underscores the company's commitment to product safety and compliance with regulatory standards.