China NMPA Product Recall - Medical angiography X-ray machine

Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary recall of its medical angiography X-ray machines, as reported by the National Medical Products Administration (NMPA) on December 6, 2021. The recall stems from a low-probability issue identified during the equipment's installation and commissioning. Specifically, if the manufacturer's commissioning procedures for confirming the maximum dose rate are not strictly followed, there is a risk that the X-ray irradiation dose rate could exceed the company's specified limits, particularly when non-standard exposure procedures are employed. This presents a critical safety concern regarding potential exposure to excessive radiation for patients and operators. The voluntary recall is classified as Level III, indicating that the use of the product is not likely to cause adverse health consequences. While the root cause is a procedural oversight during setup, its consequence could be a device operating outside its safety parameters. Shimadzu has taken this action under the oversight of the NMPA. Further details regarding specific models, specifications, and affected product batches are available in the accompanying "Medical Device Recall Event Report Form." This proactive measure aims to uphold patient safety and ensure adherence to device performance standards.