# China NMPA Product Recall - Medical angiography X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/shimadzu-enterprise-management-china-co-ltd/68247d59-d2f2-4fb7-a0e7-35c1e869c4a6/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by Shimadzu Enterprise Management (China) Co., Ltd. published October 15, 2020. Recall level: Level 3 Recall. Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its medic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shimadzu Enterprise Management (China) Co., Ltd. is voluntarily recalling medical angiography X-ray machines.
- Company Name: Shimadzu Enterprise Management (China) Co., Ltd.
- Publication Date: 2020-10-15
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 3 Recall
- Recall Reason: When a suspended C-arm device 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: Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its medical angiography X-ray machines, as reported on October 15, 2020. This action, overseen by the National Medical Products Administration (NMPA) and sourced from the Shanghai Municipal Drug Administration, addresses a potential safety concern. The primary issue involves a very small possibility of unexpected movement in the suspended C-arm device when the operating handle is used for specific operations in a particular position. The affected products are identifiable by Registration Certificate No.: 国食药监械（进）字2009第3302687号, with specific models, specifications, and batches detailed in the accompanying "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to product safety and compliance with regulatory expectations under the NMPA framework, ensuring patient and operator safety by addressing potential device malfunctions promptly.

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