China NMPA Product Recall - Medical angiography X-ray machine

Shimadzu Enterprise Management (China) Co., Ltd. has initiated a voluntary Class III recall of its medical angiography X-ray machines, as announced by the National Medical Products Administration (NMPA) on December 6, 2021. The recall addresses a critical safety concern: if the maximum dose rate is not strictly confirmed during installation and commissioning according to manufacturer procedures, there is a small probability the equipment's irradiation dose rate could exceed specified limits during non-standard exposure procedures. This presents a risk of unintended radiation exposure. The regulatory framework for this action falls under the NMPA, overseeing medical device safety in China. As a required action, Shimadzu is recalling affected product models, specifications, and batches, with detailed information available in the "Medical Device Recall Event Report Form." This proactive measure underscores the company's commitment to patient safety and regulatory compliance.