# China NMPA Product Recall - Mammography machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemers-ag/56a75737-0777-43e8-aab3-7c13bc69d5ca/
Source feed: China

> China NMPA product recall for Mammography machine by Siemers AG published March 06, 2017. Recall level: Level 2 Recall. Siemens Healthineers initiated a voluntary Class II recall of its MAMMOMAT Inspiration Mammography X

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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: 2017-03-06
- Product Name: Mammography machine
- Recall Level: Level 2 Recall
- Recall Reason: Some researchers have identified a potential slippage error that may occur when the device performs a biopsy. The system may freeze and the biopsy function may become unavailable in the following situations: 1. Pressure drop, for example, due to sudden patient movement during positioning. 2. Or, during positioning, the inversion tool is used while the positioning image is active. Due to system freezing, a re-performance of the biopsy may be necessary.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemers AG
- Summary: Siemens Healthineers initiated a voluntary Class II recall of its MAMMOMAT Inspiration Mammography X-ray Machines, as reported by the National Medical Products Administration (NMPA) on March 6, 2017, following an initial report on January 19, 2017. The recall, impacting 36 units in China, addresses a critical issue where the system may freeze and the biopsy function could become unavailable. This malfunction is primarily triggered by pressure drops, such as during sudden patient movement, or when the inversion tool is used while a positioning image is active. These conditions may also lead to a potential slippage error during biopsy procedures. To mitigate immediate risks, Siemens Healthineers issued customer advisories recommending users not to close error messages prematurely, instead urging deactivation of the target before correcting actions. Furthermore, users were cautioned against employing the reverse tool while a positioning image is active, and instructed to restart the acquisition workstation if a system freeze occurs. Siemens is committed to resolving the underlying technical issue by providing on-site upgrade services to affected customers, ensuring system functionality and patient safety.

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