China NMPA Product Recall - Mammography machine

Siemens Healthineers has initiated a voluntary Class II recall, reported on January 19, 2017, and subsequently published by the National Medical Products Administration (NMPA) of China on March 1, 2017. This recall affects their MAMMOMAT Inspiration Mammography X-ray Machines. No specific NMPA inspection dates were detailed in this voluntary recall document; rather, it was reported by Siemens Healthineers.The core issue is that the system may freeze and the biopsy function may become unavailable under specific operating conditions. These include a pressure drop, such as during sudden patient movement during active localization, or when the inversion tool is used while the localization image is active. This malfunction necessitates the re-performance of biopsies.To address this, Siemens Healthineers first issued customer notifications (XP040/16/S) advising users on interim measures to avoid system freezing, such as deactivating targets when error messages appear and restarting the workstation if a freeze occurs. For a permanent resolution, Siemens Healthineers will provide free, on-site software upgrade services (recall number XP041/16/S) to all affected customers, including the 36 units imported into China, with service engineers arranging these upgrades directly.