China NMPA Product Recall - Cardiovascular imaging system

On October 15, 2020, Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its cardiovascular angiography system. This action, reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a potential safety concern with the device. The main issue identified is the possibility of the suspended C-arm device moving unexpectedly. This can occur when the C-arm is in a specific position and the operating handle is used for a particular operation. While described as a very small possibility, the company deemed a recall necessary to ensure patient safety and product reliability. The regulatory framework overseeing this recall includes the NMPA, which is the national authority responsible for medical device oversight in China, and its local counterpart, the Shanghai Municipal Drug Administration. Shimadzu's decision to conduct a voluntary recall signifies their proactive approach to product safety. Specific details regarding the affected product models, specifications, and batches are contained within the "Medical Device Recall Event Report Form," an attachment to the NMPA's public notice. The required action for Shimadzu is to manage this recall effectively, ensuring that all potentially affected devices are addressed in accordance with regulatory guidelines to mitigate any risks to patients and healthcare professionals.