# China NMPA Product Recall - Mammography equipment

Source: https://www.globalkeysolutions.net/records/china_product_recall/fujifilm-china-investment-co-ltd/c63a752a-d5d6-4d91-bb7e-e08382dc4045/
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. proactively initiated a voluntary Level III recall for specifi

---

## 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: The manufacturer's name on the labels of certain batches of mammography equipment components is incorrect; there are also typos in the submitted technical documents. These issues are unrelated to product safety, and customers can continue to use the 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. proactively initiated a voluntary Level III recall for specific batches of its mammography equipment, as reported on January 25, 2019. This action was taken to ensure full compliance with Chinese National Medical Products Administration (NMPA) regulations. The company identified two distinct issues through internal discovery, not an external inspection: firstly, certain component labels on the affected equipment contained incorrect manufacturer names; and secondly, typographical errors were present in the submitted technical documents. Fujifilm explicitly clarified that these issues do not pose any risk to product safety, allowing customers to continue using the mammography equipment without interruption. The Level III classification signifies that the issue is unlikely to cause adverse health consequences, but correction is still necessary for regulatory conformity. This voluntary recall underscores Fujifilm's commitment to maintaining meticulous accuracy in product labeling and documentation, reinforcing their adherence to stringent regulatory frameworks even when patient safety is not compromised. Detailed information regarding the precise models, specifications, and batches involved is provided in the "Medical Device Recall Event Report Form" attachment.

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