China NMPA Product Recall - Mobile X-ray machine

Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its MobileDiagnost wDR 2.1 portable X-ray machines in China, as reported by the National Medical Products Administration (NMPA) on March 25, 2021, with further publication by the Shanghai Municipal Drug Administration on May 9, 2021. The recall, documented internally as FCO71200202, addresses a critical compliance issue regarding the device's laser emitter. The core problem stems from the incorrect integration of a Class I laser emitter in these systems, contrary to the required Class II classification for products sold in China. While Class I lasers are acceptable internationally, their use in China presents significant registration and product parameter conflicts within the country's regulatory framework. This discrepancy rendered the product non-compliant with its approved registration certificate (No.: 国械注进20182300009), despite successful overseas usage. As a result, Philips (China) is undertaking this recall to rectify the regulatory non-conformity. Detailed information regarding the affected product models, specifications, and specific batches is available in the accompanying "Medical Device Recall Event Report Form." This action underscores the stringent regulatory requirements enforced by the NMPA for medical devices within China.