# China NMPA Product Recall - Angiography X-ray system

Source: https://www.globalkeysolutions.net/records/china_product_recall/shimadzu-enterprise-management-china-co-ltd/22913909-7c6a-4000-b2da-829eb23147cf/
Source feed: China

> China NMPA product recall for Angiography X-ray system by Shimadzu Enterprise Management (China) Co., Ltd. published October 15, 2020. Recall level: Level 3 Recall. On October 15, 2020, Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class II

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shimadzu Enterprise Management (China) Co., Ltd. voluntarily recalls its angiography X-ray system.
- Company Name: Shimadzu Enterprise Management (China) Co., Ltd.
- Publication Date: 2020-10-15
- Product Name: Angiography X-ray system
- Recall Level: Level 3 Recall
- Recall Reason: When a suspended C-arm is in a specific position and a specific operation is performed using the operating handle, the C-arm may move unexpectedly.
- Discovering Company: Shimadzu Enterprise Management (China) Co., Ltd.
- Manufacturing Company: Shimadzu Enterprise Management (China) Co., Ltd.
- Summary: On October 15, 2020, Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its angiography X-ray system. This action was reported to and overseen by the National Medical Products Administration (NMPA) and stemmed from an identified safety concern. The primary issue involves the suspended C-arm device, which may exhibit unexpected movement when operated with the handle in a specific position. This malfunction poses a potential risk during medical procedures. The recall specifically targets angiography X-ray systems, identified by Registration Certificate No.: 
国食药监械（进）字2007第3301765号. While the document specifies an attachment for detailed product models, specifications, and batches involved, the core action required by the company is the proactive removal of affected devices from the market to ensure patient safety and compliance with regulatory standards. This voluntary recall highlights the company's commitment to addressing potential product safety issues under the regulatory oversight of the NMPA, ensuring medical device integrity within China's healthcare system.

Company: https://www.globalkeysolutions.net/companies/shimadzu-enterprise-management-china-co-ltd/45f5c532-93c8-4552-9b59-604e7c9cba23/