China NMPA Product Recall - Mobile X-ray machine

On September 16, 2020, Philips (China) Investment Co., Ltd. initiated a voluntary Class III recall of its Mobile X-ray machines, specifically involving the MobileDiagnost wDR system (Registration Certificate No.: 国械注进20182300009). This action was publicized by the National Medical Products Administration (NMPA) through the Shanghai Municipal Drug Administration website. The primary issue identified was that the MobileDiagnost wDR systems installed in China were equipped with only an English laser label, critically lacking the required secondary Chinese laser label. This omission represents a significant regulatory non-compliance, impacting product usability and safety information for local users in China. As a result, Philips (China) Investment Co., Ltd. proactively moved to recall the affected devices. This recall underscores the strict adherence required by the NMPA's regulatory framework concerning medical device labeling standards, ensuring that essential product information is readily accessible and understandable to the domestic market. Further details regarding specific product models, specifications, and batches involved in this recall are documented in the "Medical Device Recall Event Report Form."