China NMPA Product Recall - Medical magnetic resonance imaging system

Philips Medical Systems Nederland B.V. initiated a voluntary Class III recall of specific models and batches of its Medical Magnetic Resonance Imaging Systems. The recall, reported by Philips (China) Investment Co., Ltd., was prompted by the products' non-compliance with the certification requirements stipulated by the Japanese Pharmaceutical Administration Law. This action, published on February 28, 2020, falls under the oversight of the National Medical Products Administration (NMPA) in China, indicating the global implications of regulatory adherence. While the issue stemmed from compliance with Japanese regulations, the recall impacts products registered under Chinese certification (CFDA Imported 2013 No. 3284026 and No. 3284170). The company is taking proactive steps to address the identified issues. Detailed information regarding the affected product models, specifications, and batches is available in the associated "Medical Device Recall Event Report Form" attachment, ensuring transparency and providing necessary specifics for stakeholders. This voluntary recall underscores the importance of stringent regulatory compliance for medical devices across international markets.