China NMPA Product Recall - Medical angiography X-ray machine

Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its medical angiography X-ray machines, as reported by the National Medical Products Administration (NMPA) on October 15, 2020. The recall was prompted by a potential issue where the suspended C-arm device could experience unexpected movement during specific operations and positions when the operating handle was used. This action aligns with the regulatory framework governed by the NMPA, which oversees medical device safety and recalls in China. The company voluntarily opted for this recall to address the identified safety concern, emphasizing a proactive approach to product reliability. The specific product models, specifications, and batch numbers affected by this recall are detailed in the accompanying "Medical Device Recall Event Report Form," indicating the scope of the required actions to mitigate potential risks associated with the equipment.