China NMPA Product Recall - Medical angiography X-ray machine

Shimadzu Enterprise Management (China) Co., Ltd. initiated a Class II voluntary recall for its medical angiography X-ray machine (Registration Certificate No.: 20153302148), as reported by the National Medical Products Administration (NMPA) on January 14, 2019. This action, processed through the Shanghai Food and Drug Administration, addresses two significant product concerns. Firstly, in extremely rare circumstances, internal equipment noise could interfere with the synchronous transmission of image data, potentially compromising diagnostic image quality. Secondly, under abnormal operational scenarios, if fluoroscopy is performed immediately following equipment startup and the initiation of a registration inspection, the device's application may unexpectedly restart. This restart raises further concerns regarding the reliable performance of subsequent normal fluoroscopy and radiography procedures. The company’s voluntary recall aims to address these identified potential deficiencies to ensure the continued safety and efficacy of the medical device in clinical settings, adhering to the NMPA's regulatory framework for medical product oversight. This demonstrates the company's commitment to patient safety and product integrity.