# China NMPA Product Recall - X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/shimadzu-corporation/d45926f1-7855-4129-ae90-56a0fd10ba0a/
Source feed: China

> China NMPA product recall for X-ray imaging system by Shimadzu Corporation published August 11, 2017. Recall level: Level 3 Recall. Shimadzu International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specif

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shimadzu International Trading (Shanghai) Co., Ltd. voluntarily recalls X-ray imaging systems.
- Company Name: Shimadzu Corporation
- Publication Date: 2017-08-11
- Product Name: X-ray imaging system
- Recall Level: Level 3 Recall
- Recall Reason: A very small number of cracks may occur in the fixed shaft section of the X-ray tube support.
- Discovering Company: Shimadzu International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Shimadzu Corporation
- Summary: Shimadzu International Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific X-ray imaging systems, a measure reported to the National Medical Products Administration (NMPA) on August 11, 2017. The recall was prompted by the discovery of potential cracks in a very small number of these devices, identified by Registration No. 20053311268(Revised). While the exact inspection dates are not provided, the company proactively reported the issue and commenced the recall process. This action aligns with the NMPA's regulatory framework, which mandates manufacturers to address product quality concerns and ensure medical device safety. The required action involved the voluntary removal of the affected X-ray imaging systems from the market to mitigate any potential risks. Detailed information regarding the models, specifications, and batch numbers of the affected products is available in the associated "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/shimadzu-corporation/e01393c0-317f-4e7f-a568-ed5e66f88ae2/