# China NMPA Product Recall - Cardiovascular X-ray device

Source: https://www.globalkeysolutions.net/records/china_product_recall/shimadzu-enterprise-management-china-co-ltd/c52b6e68-639e-40ba-8a7a-aa82dbc50169/
Source feed: China

> China NMPA product recall for Cardiovascular X-ray device 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 cardi

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shimadzu Enterprise Management (China) Co., Ltd. voluntarily recalls cardiovascular angiography X-ray equipment.
- Company Name: Shimadzu Enterprise Management (China) Co., Ltd.
- Publication Date: 2020-10-15
- Product Name: Cardiovascular X-ray device
- 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: Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class III recall of its cardiovascular system angiography X-ray device, as announced by the National Medical Products Administration (NMPA) on October 15, 2020. This action addresses a potential safety concern where the suspended C-arm device might experience unexpected movement during specific operations when the operating handle is used in a particular position. Although described as an "extremely small possibility," this issue could compromise patient safety and device performance.
The NMPA, the governing regulatory body in China, oversees this recall to ensure compliance with medical device safety standards. A Class III recall indicates that the product defect has a low probability of causing serious adverse health consequences, but corrective action is still necessary to mitigate potential risks. Shimadzu Enterprise Management (China) Co., Ltd. is responsible for implementing this recall, which involves identifying and addressing all affected units of the cardiovascular system angiography X-ray device. Further details regarding the specific product models, specifications, and batches involved in this recall are provided in an accompanying Medical Device Recall Event Report Form. This proactive measure aims to ensure the continued safety and reliability of medical devices in clinical use.

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