China NMPA Product Recall - MobileDiagnost WDR (Mobile Digital Medical X-ray Imaging System)

Philips Healthcare (Suzhou) Co., Ltd. has initiated a voluntary Level 3 recall for its Mobile Digital Medical X-ray Imaging System (model: MobileDiagnost wDR) due to the absence of a required Class 2 Chinese laser instruction label. The company identified this issue during internal testing, reporting it on September 14, 2020, with the National Medical Products Administration (NMPA) publishing the recall on October 26, 2020. The primary issue stems from non-compliance with the Chinese national standard GB7247.1-2012, which mandates the affixing of such labels on medical devices. While no injuries have been reported, this regulatory framework ensures products meet national safety and information standards. As corrective actions, Philips has notified affected customers. Field engineers will conduct on-site updates to affix the missing Chinese laser instruction labels to all 22 affected MobileDiagnost wDR units sold in China, ensuring full compliance.