# China NMPA Product Recall - Mammography machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemers-ag/6ced7af3-9d5d-4df9-b3d7-da8c88de3d5c/
Source feed: China

> China NMPA product recall for Mammography machine by Siemers AG published March 01, 2017. Recall level: Level II. Siemens Healthineers has initiated a voluntary Class II recall, reported on January 19, 2017, and su

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers voluntarily recalls mammography X-ray machines
- Company Name: Siemers AG
- Publication Date: 2017-03-01
- Product Name: Mammography machine
- Recall Level: Level II
- Recall Reason: During a biopsy, the system may freeze and the biopsy function may become unavailable. This can occur due to a drop in pressure (e.g., due to sudden patient movement during active localization) or during localization when the inversion tool is used while the localization image is active. If the system freezes, the biopsy may need to be re-performed.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemers AG
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/siemers-ag/1c09d1a2-e758-49e2-ae60-530e6a26e88d/