China NMPA Product Recall - Mobile digital medical X-ray imaging system

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Level 3 recall on November 29, 2021, for its Mobile Digital Medical X-ray Imaging System, specifically the MobileDiagnost wDR model. The recall was prompted by the potential absence of an ionizing radiation warning label on the manual switch assembly of these devices. This issue was identified as a non-conformance impacting patient and user safety information regarding radiation exposure.

The recall affects 11 units distributed within China. Under the oversight of the National Medical Products Administration (NMPA), Philips Healthcare (Suzhou) Co., Ltd. is undertaking a corrective action plan. This plan involves Philips Field Service Engineers visiting all affected units. Their primary task is to inspect each MobileDiagnost wDR system, and if the critical radiation warning label is found to be missing, they will affix it to ensure compliance and proper safety communication. This proactive measure aims to rectify the identified labeling deficiency and uphold regulatory standards for medical device safety.