# 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/2a63fb9c-5096-4ab2-89be-715fc8d38199/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Suzhou Fujifilm Imaging Equipment Co., Ltd. published February 21, 2020. Recall level: Level 3 Recall. On February 21, 2020, Suzhou Fujifilm Imaging Equipment Co., Ltd. voluntarily initiated a Class III 

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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: 2020-02-21
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: The description of the bulb inside the limiter in the Chinese instruction manual CD (Version H) that comes with this product is incorrect and needs to be replaced with the correct instruction manual CD (Version I). This issue does not affect the safety and effectiveness of the product, and the product can continue to be used.
- Discovering Company: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Manufacturing Company: Suzhou Fujifilm Imaging Equipment Co., Ltd.
- Summary: On February 21, 2020, Suzhou Fujifilm Imaging Equipment Co., Ltd. voluntarily initiated a Class III recall for its Digital Medical X-ray Imaging System, identified by NMPA Registration Certificate 20152060234, across Mainland China. The recall was necessitated by an error found in the Chinese instruction manual CD, Version H, which contained an inaccurate description of the bulb situated within the collimator component. Affected products include models with identification numbers such as 87235066 and 97135095.

Operating under the regulatory guidance of the National Medical Products Administration (NMPA), the company assessed the situation and confirmed that this discrepancy did not constitute an adverse event, and the operational integrity of the Digital Medical X-ray Imaging System remains uncompromised, allowing continued use. The primary corrective action involves the company replacing the incorrect instruction manual CD (Version H) with the accurate Version I to ensure precise product documentation for all affected devices. This action underscores the company's commitment to maintaining high standards of product information within the medical device sector.

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