China NMPA Product Recall - Mammography machine

Siemens Healthineers initiated a voluntary Class II recall for its MAMMOMAT Inspiration Mammography X-ray Machines, as reported to the National Medical Products Administration (NMPA) on January 19, 2017, with public notification on February 21, 2017. The recall affects 36 units imported into China. The primary issue identified is that the system may freeze and the biopsy function could become unavailable during stereotactic biopsy procedures. This malfunction can occur due to sudden patient movement causing pressure drops or incorrect use of the inversion tool while a positioning image is active, potentially requiring a biopsy to be re-performed. In response, Siemens Healthineers issued customer notifications (XP040/16/S) detailing the risks and preventative measures. Customers are advised, if an error message appears, to deactivate the target, close the error window, and restart the operation; a full workstation restart is necessary if the system freezes. Furthermore, Siemens committed to providing field software upgrades (XP041/16/S) to resolve the underlying technical issue. Siemens service engineers are contacting affected customers to implement these necessary system repairs. This proactive measure falls under the regulatory oversight of the NMPA to ensure medical device safety.