# China NMPA Product Recall - Digital medical X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/suzhou-fujifilm-imaging-equipment-co-ltd/9db9ac7a-32cd-42d5-bf1d-e888cc86c0eb/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Suzhou Fujifilm Imaging Equipment Co., Ltd. published May 03, 2017. Recall level: Level 3 Recall. Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a voluntary Class III recall for 12 units of i

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Suzhou Fujifilm Imaging Equipment Co., Ltd. voluntarily recalls digital medical X-ray imaging systems.
- Company Name: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Publication Date: 2017-05-03
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: The changes to the product structure and software version were approved by the Jiangsu Provincial Drug Administration on January 9, 2017. Due to the delay in the production process changes, the products manufactured by the company after January 9 cannot meet the requirements of the approval document. In order to ensure that the company's products fully comply with the relevant regulations, the company has decided to recall 12 units of these products that have not yet been or are about to be used by the end users.
- Discovering Company: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Manufacturing Company: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Summary: Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a voluntary Class III recall for 12 units of its Digital Medical X-ray Imaging Systems (Registration No.: Su Xie Zhu Zhun 20152300234). The National Medical Products Administration (NMPA) publicized this recall on May 3, 2017, following the company's report on April 26, 2017. The primary issue was a failure to promptly implement approved structural changes and software upgrades, which the Jiangsu Provincial Drug Administration had approved on January 9, 2017. Products manufactured after this date did not conform to the updated regulatory requirements, although this was not classified as an adverse event. As a corrective action, Suzhou Fujifilm will identify one unit delivered to a hospital but not yet installed, and eleven units still in the Fujifilm (China) Investment Co., Ltd. warehouse. All affected units will be transported back to the company for modification and inspection to ensure compliance with revised technical requirements before redelivery.

Company: https://www.globalkeysolutions.net/companies/suzhou-fujifilm-imaging-equipment-co-ltd/05879a2b-0ed5-4e2a-be94-59a6db3bddf7/