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, and published on February 21, 2017. The recall addresses a critical safety concern where the system may freeze, rendering the biopsy function unavailable. This issue can occur due to sudden patient movement causing a pressure drop during active localization, or if the inversion tool is used while the localization image is active. Such system freezes could lead to the need for repeat biopsies. In response, Siemens Healthineers has outlined several corrective actions. They issued a customer notification letter (XP040/16/S) advising users on immediate mitigation strategies. These include deactivating the target before closing error messages and refraining from using the inversion tool when an image is active. In the event of a system freeze, restarting the acquisition workstation is necessary. Crucially, Siemens will provide a free, on-site software upgrade service (recall number XP041/16/S) to all 36 affected units in regions including Germany, Canada, and China. Service engineers will proactively contact customers to schedule these essential updates, ensuring the resolution of this critical software anomaly.