China NMPA Product Recall - Artis one medical angiography X-ray machine

The National Medical Products Administration (NMPA) issued a notice on September 23, 2020, detailing a voluntary Class III recall initiated by Siemens (Shenzhen) Magnetic Resonance Co., Ltd. The recall pertains to specific models of their Artis one medical angiography X-ray machines, identifiable by Registration Certificate No.: 20143062055. Siemens proactively identified a critical issue during routine site monitoring: a potential for intermittent monitor failure within the examination room of the affected devices. This malfunction could compromise the operational integrity and safety of the X-ray machines. Operating under the NMPA's regulatory framework, with information sourced via the Guangdong Provincial Drug Administration, Siemens is implementing this recall to address the potential defect. While specific customer actions beyond the recall initiation are not fully detailed in this public notice, further comprehensive information regarding affected products and required actions is directed to be available in the "Medical Device Recall Event Report Form" and an attached "Siemens Recall Incident Report Form.pdf."