China NMPA Product Recall - Medical angiography X-ray machine

On December 6, 2021, Shimadzu Enterprise Management (China) Co., Ltd. voluntarily initiated a Class III recall for specific models of its medical angiography X-ray machines. This action was taken due to a potential safety concern identified with the equipment. There is a very small probability that if the maximum dose rate is not strictly confirmed according to the manufacturer's detailed commissioning procedures during the initial installation and setup, the irradiation dose rate could exceed the company's specified limits when performing non-standard exposure procedures. This issue could pose a risk to patient safety by potentially exposing them to higher-than-intended radiation levels. The recall, reported via the Shanghai Municipal Drug Administration Website, falls under the regulatory oversight of the National Medical Products Administration (NMPA), referenced by Index No. JGXX-2021-10672. The affected devices carry Registration Certificate No.: 国食药监械（进）字2011第3303994号（更）, with comprehensive details on models, specifications, and batches provided in an attached "Medical Device Recall Event Report Form." This voluntary recall underscores Shimadzu Enterprise Management's commitment to product safety and compliance with medical device regulations, aiming to rectify the identified issue and ensure the consistent and safe operation of their X-ray machines in clinical settings.