# 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/a5550525-7c48-42a1-93e6-ebe88289d246
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Suzhou Fujifilm Imaging Equipment Co., Ltd. published May 16, 2017. Recall level: Level 3 Recall. Suzhou Fujifilm Imaging Equipment Co., Ltd. initiated a voluntary Class III recall of its Digital Me

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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: 2017-05-16
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: Production was not organized in a timely manner in accordance with the requirements after the registration change.
- 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 its Digital Medical X-ray Imaging Systems (Registration No.: Su Xie Zhu Zhun 20152300234), announced on May 16, 2017. This action was taken under the regulatory oversight of China's National Medical Products Administration (NMPA).
The primary reason for the recall stemmed from the company's failure to organize production in a timely manner, which was required after a registration change for the medical device. This operational lapse meant that production did not adhere to the updated regulatory requirements, necessitating the recall of the affected units to ensure compliance and product safety.
As a required action, the company conducted a voluntary Class III recall, indicating a commitment to rectifying the identified issue. Further details regarding the specific models, specifications, and batch numbers involved are documented in the official Medical Device Recall Event Report Form. This incident underscores the critical importance of strictly adhering to production protocols and promptly incorporating regulatory updates following product registration changes within the medical device manufacturing sector.

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