China NMPA Product Recall - X-ray machine

Philips (China) Investment Co., Ltd. initiated a voluntary Class II recall of its X-ray machines on May 14, 2020. This action, reported by the Shanghai Municipal Drug Administration under the oversight of the National Medical Products Administration (NMPA), addresses a potential critical safety concern. The core issue identified is the possible incorrect installation of a thermal switch within the three-phase transformer, specifically located in the System Power Distribution Unit (SPDU) of the affected X-ray systems. This installation error could lead to equipment malfunction, posing risks to patient safety and operational reliability. The recall pertains to X-ray machines bearing Registration Certificate No. 国械注进20192060236. Philips (China) Investment Co., Ltd. is taking proactive steps to manage this deviation from quality standards, ensuring compliance with regulatory frameworks governing medical devices in China. Detailed information regarding specific product models, specifications, and affected batches is made available through a "Medical Device Recall Event Report Form," which stakeholders are encouraged to consult for further guidance on the required actions to address the recalled units. The company's immediate action aims to mitigate potential risks associated with the identified manufacturing defect.