China NMPA Product Recall - Medical angiography X-ray machine

Shimadzu Corporation, through its subsidiary Shimadzu Enterprise Management (China) Co., Ltd., has initiated a voluntary Class III recall of specific medical angiography X-ray machines (National Medical Device Registration Certificate No. 20153062148). The recall, publicly reported by the National Medical Products Administration (NMPA) on January 23, 2024, addresses a significant safety concern. The core issue involves the equipment's image processing unit. When this unit is replaced and a particular system version is installed, the device may inaccurately display the air kerma value, showing a higher dose than what is actually administered. This discrepancy poses a potential risk to patients, as healthcare professionals might operate under the false assumption of a higher radiation exposure, potentially leading to incorrect treatment decisions or patient management. This voluntary recall falls under the regulatory oversight of the NMPA in China, highlighting the company's commitment to product safety and compliance. Shimadzu Corporation is undertaking this corrective action to mitigate the identified risk and ensure the accuracy of their medical devices. Affected product models, specifications, and batch information are detailed in accompanying documents, including a "Medical Device Notice" and a "Medical Device Recall Event Report Form," which provide further guidance on the scope and procedures of the recall.