China NMPA Product Recall - Medical angiography X-ray machine

Siemens Healthineers initiated a voluntary Class II recall of its medical angiography X-ray machine, as reported by the National Medical Products Administration (NMPA) on April 2, 2021. The recall addresses an identified issue involving occasional increased wear on the cable at the built-in C-arm cable outlet of some affected systems. This wear poses a risk of cable damage, which could lead to limited system functionality. The NMPA, China's primary medical device regulatory authority, oversees this action, with a Class II designation indicating that the product may cause temporary or reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Siemens Healthineers' required action is to conduct a voluntary recall. Detailed information concerning the specific models, specifications, and batches of the affected products is available in the