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

Source: https://www.globalkeysolutions.net/records/china_product_recall/shimadzu-enterprise-management-china-co-ltd/e0275dbe-a088-4de3-a437-b7a3bb589b06/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by Shimadzu Enterprise Management (China) Co., Ltd. published January 14, 2019. Recall level: Level 2 Recall. Shimadzu Enterprise Management (China) Co., Ltd. initiated a voluntary Class II recall of its medica

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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: 2019-01-14
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: In extremely rare cases, equipment malfunction noise may interfere with the transmission and synchronization of image data, potentially affecting image quality. In abnormal operating conditions, if the equipment is started and fluoroscopy is performed immediately after registration and inspection, it may cause the application to restart, and normal fluoroscopy and photography may be impossible after the restart.
- 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 II recall of its medical angiography X-ray machine on January 14, 2019. This action, reported to the National Medical Products Administration (NMPA), addresses two key operational issues. Firstly, the company found that in rare circumstances, equipment malfunction noise could interfere with the synchronous transmission of image data, potentially compromising image quality. Secondly, under specific abnormal operating conditions, performing fluoroscopy immediately after equipment startup and registration inspection could lead to the application restarting. This restart then presented concerns regarding the normal functionality of subsequent fluoroscopy and radiography. The recall demonstrates Shimadzu's adherence to regulatory frameworks for medical device safety in China and aims to mitigate potential risks associated with the identified issues. Detailed information regarding affected product models, specifications, and batches is provided in the accompanying Medical Device Recall Event Report Form.

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