China NMPA Product Recall - Medical angiography X-ray machine

On October 30, 2020, Siemens Healthineers voluntarily initiated a Class II recall of its Medical Angiography X-ray Machines under the oversight of the National Medical Products Administration (NMPA). The company identified a critical potential problem involving the protection diodes within certain electronic components of a few generators. There is a small risk that these diodes may not provide sufficient overvoltage protection, which could lead to damage of specific electronic components. Such damage has the potential to limit the timely operation of the system and cause significant program delays during medical procedures. Although Siemens Healthineers had not received any reports of patient injuries directly attributable to this issue by the report date, the voluntary recall was implemented as a proactive measure to address this potential risk. The affected products include Medical Angiography X-ray Machines with registration certificate numbers 20163304718 and 20183300137. This action demonstrates Siemens Healthineers' commitment to patient safety and product reliability, ensuring adherence to the stringent regulatory requirements established by the NMPA for medical devices.