# China NMPA Product Recall - Mammography equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/fujifilm-china-investment-co-ltd/1b0ace32-61b3-4d25-b10b-8066e5b0a91c/
Source feed: China

> China NMPA product recall for Mammography equipment by Fujifilm (China) Investment Co., Ltd. published January 25, 2019. Recall level: Level 3 Recall. Fujifilm (China) Investment Co., Ltd. initiated a voluntary Class III recall of specific mammography

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Fujifilm (China) Investment Co., Ltd. is voluntarily recalling mammography equipment.
- Company Name: Fujifilm (China) Investment Co., Ltd.
- Publication Date: 2019-01-25
- Product Name: Mammography equipment
- Recall Level: Level 3 Recall
- Recall Reason: 1. The manufacturer's name on the labels of certain batches of mammography X-ray equipment components is incorrect; 2. There are typos in the submitted technical documents. These issues are unrelated to product safety, and customers can continue to use this product. To comply with Chinese regulations, Fujifilm has voluntarily initiated this recall.
- Discovering Company: Fujifilm (China) Investment Co., Ltd.
- Manufacturing Company: Fujifilm (China) Investment Co., Ltd.
- Summary: Fujifilm (China) Investment Co., Ltd. initiated a voluntary Class III recall of specific mammography equipment on January 25, 2019, as reported by the National Medical Products Administration (NMPA). This action was taken to ensure compliance with Chinese regulatory requirements. The recall addresses two distinct issues discovered by Fujifilm: an incorrect manufacturer's name printed on the labels of certain product batches and typographical errors found within the submitted technical documentation. Crucially, the NMPA document emphasizes that these identified issues do not compromise product safety, and customers can safely continue using the equipment. Fujifilm proactively undertook this recall as a corrective measure to align with regulatory standards, rather than due to any risk to patient health or equipment functionality. The "Medical Device Recall Event Report Form" provides further details on the specific models, specifications, and batches impacted by this recall. This highlights Fujifilm's commitment to regulatory adherence and transparent communication regarding minor compliance deviations.

Company: https://www.globalkeysolutions.net/companies/fujifilm-china-investment-co-ltd/525125aa-bfe1-426a-bd3d-521f5273fa84/