China NMPA Product Recall - Cardiovascular X-ray device

Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its cardiovascular system angiography X-ray device on October 15, 2020. This action, reported through the National Medical Products Administration (NMPA), addresses a critical safety concern identified with the medical equipment. The primary issue involves the unexpected movement of the device's suspended C-arm. Specifically, when the C-arm is in a particular position and the operating handle is used for a specific function, the C-arm may move unintentionally. This malfunction poses a potential risk to patient safety and the integrity of medical procedures. Under the regulatory guidance of the NMPA, Shimadzu is proactively withdrawing the affected products from the market. While the document does not specify inspection dates, the company's self-reporting of the issue and subsequent recall demonstrate adherence to medical device safety protocols within China's regulatory framework. The recall encompasses specific models, specifications, and batches, with comprehensive details provided in the associated "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential hazards and ensure the reliability and safety of medical devices used in clinical settings.