China NMPA Product Recall - Medical angiography X-ray machine

Shimadzu Corporation, through its entity Shimadzu Enterprise Management (China) Co., Ltd., has initiated a voluntary Class III recall for its medical angiography X-ray machines. This action, reported on January 23, 2024, addresses a critical manufacturing defect within the internal circuit board of certain flat panel detectors. This defect has the potential to cause abnormal system images during operation, which could compromise the diagnostic accuracy and safety of the medical device.The recall pertains to devices registered under National Medical Device Registration Certificate No. 20153062148. The National Medical Products Administration (NMPA) oversees this regulatory action, ensuring compliance with medical device safety standards. As a Class III recall, it indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences.In response to this identified issue, Shimadzu Corporation is actively recalling the affected units. Further comprehensive details regarding the specific models, specifications, and batch numbers of the impacted medical angiography X-ray machines are provided in the official 'Medical Device Recall Event Report Form' released by the company. This voluntary recall underscores the company's commitment to product safety and adherence to regulatory requirements set forth by the NMPA.