# China NMPA Product Recall - Mammography machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/5a80cf6f-ba95-488c-bd30-dbb868a87be4/
Source feed: China

> China NMPA product recall for Mammography machine by Siemens Healthineers Co., Ltd. published February 21, 2017. Recall level: Level II. The National Medical Products Administration (NMPA) announced on February 21, 2017, details regardin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers voluntarily recalls mammography X-ray machines
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2017-02-21
- Product Name: Mammography machine
- Recall Level: Level II
- Recall Reason: When performing a biopsy, the system may freeze and the biopsy function may become unavailable.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on February 21, 2017, details regarding a voluntary Class II recall initiated by Siemens Healthineers. The recall addresses an issue with certain mammography machines where the system may freeze, and the biopsy function could become unavailable when performing biopsy procedures. This critical malfunction directly impacts the device's intended use and patient safety during diagnostic interventions. Siemens Healthineers proactively decided to recall the affected products to mitigate potential risks to patients and ensure the reliability of their medical equipment. A Class II recall, as designated by the NMPA, indicates that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. The company has documented comprehensive information on specific product specifications and batches in a 'Medical Device Recall Event Report Form'. This action demonstrates the company's commitment to adhering to regulatory standards set by the NMPA and ensuring product safety in the healthcare sector.

Company: https://www.globalkeysolutions.net/companies/siemens-healthineers-co-ltd/92a17b04-898c-4eba-81aa-91900b470181/