China NMPA Product Recall - Medical angiography X-ray machine

The National Medical Products Administration (NMPA) issued an announcement on October 15, 2020, detailing a voluntary Class III recall initiated by Shimadzu Enterprise Management (China) Co., Ltd. The recall pertains to their medical angiography X-ray machines, specifically due to a recognized potential for the suspended C-arm device to exhibit unexpected movement. This rare occurrence is identified during particular operations when the operating handle is engaged in a specific position. Shimadzu Enterprise Management (China) Co., Ltd. proactively decided to recall the affected units to address this potential malfunction and uphold patient safety. A Class III recall typically indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences, but the issue still warrants corrective action. This regulatory action, documented under NMPA Index No. JGXX-2020-10518, underscores the company's commitment to product quality and compliance within the regulatory framework of the NMPA. Required actions involve the company providing detailed information on affected product models, specifications, and batch numbers, available in the "Medical Device Recall Event Report Form," to facilitate the safe return and resolution of the units. This measure ensures that all medical devices meet stringent safety and performance standards.