# 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/9c6f4060-43c6-43f7-83e5-dbfde794357e/
Source feed: China

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

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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: 2017-05-12
- 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 of 12 units of its Digital Medical X-ray Imaging Systems (Registration No.: Su Xie Zhu Zhun 20152300234). The recall was publicly announced by the National Medical Products Administration (NMPA) on May 12, 2017, following the company's report on April 26, 2017. The primary issue arose from a delay in organizing production according to revised requirements after the Jiangsu Provincial Drug Administration approved changes to the product's structural composition and software on January 9, 2017. As a result, units manufactured after this date did not conform to the updated approval document. Under the NMPA's regulatory framework, the company's required actions involve immediately identifying, retrieving, and transporting all 12 affected units back to Suzhou Fujifilm. These products will then be modified and thoroughly inspected to ensure full compliance with the updated technical specifications before re-release.

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