China NMPA Product Recall - Mobile X-ray machine

On November 24, 2021, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall for its MobileDiagnost wDR system, a mobile X-ray machine. The company identified that the manual switch assembly on these devices might be missing an essential ionizing radiation warning label. This omission represents a potential safety concern, as proper labeling is crucial for informing users of radiation hazards associated with the equipment. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA), with the recall notice published by the Shanghai Municipal Drug Administration. Affected products are identified by Registration Certificate No. 20182300009. Philips (China) Investment Co., Ltd. is taking proactive measures to address the labeling deficiency across all impacted units. Customers and healthcare providers using the MobileDiagnost wDR system are advised to consult the detailed "Medical Device Recall Event Report Form" for specific information regarding the models, specifications, and batch numbers involved in this recall. This voluntary action reinforces the company's dedication to product safety and adherence to medical device regulations, ensuring all necessary warnings are present to protect both users and patients from potential risks.