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

Source: https://www.globalkeysolutions.net/records/china_product_recall/shimadzu-enterprise-management-china-co-ltd/767fadbd-f8ac-494c-b433-96c375b3f878/
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. 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. 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: On October 15, 2020, Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its medical angiography X-ray machine. This action was publicly reported by the National Medical Products Administration (NMPA) through the Shanghai Municipal Drug Administration Website. The recall stems from a reported safety concern where the suspended C-arm device, under specific operating conditions and positions, may exhibit unexpected movement when the operating handle is manipulated. This potential malfunction poses a risk to patient safety and operational integrity during medical procedures. The company's decision to recall the device, identified by Registration Certificate No.: ". The recall is a voluntary action by Shimadzu to address a potential safety concern with their medical angiography X-ray machine, specifically regarding the unexpected movement of the suspended C-arm device under certain operational conditions. This Level III recall was reported on October 15, 2020, and aligns with the regulatory framework overseen by the National Medical Products Administration (NMPA). While specific inspection dates were not provided, the company is taking proactive steps, requiring stakeholders to consult the "Medical Device Recall Event Report Form" for detailed information on affected models and necessary actions.

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