# China NMPA Product Recall - Mammography machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemers-ag/8c94dc23-bc86-4a70-a964-a8fc45296efb/
Source feed: China

> China NMPA product recall for Mammography machine by Siemers AG published February 21, 2017. Recall level: Level II. Siemens Healthineers initiated a voluntary Class II recall for its MAMMOMAT Inspiration Mammography 

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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: 2017-02-21
- Product Name: Mammography machine
- Recall Level: Level II
- Recall Reason: The company discovered that the system might freeze and the biopsy function might become unavailable when performing biopsies with the product in question. This could be due to a drop in pressure (such as patient movement) or the use of a reversal tool during localization or when the localization image is active. Therefore, it may be necessary to re-perform the biopsy.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemers AG
- Summary: 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.

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