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

Source: https://www.globalkeysolutions.net/records/china_product_recall/shimadzu-enterprise-management-china-co-ltd/7a6fc3c6-ba63-4f2e-8e44-a89bb70936db/
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 Class II voluntary recall for 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: 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. Under abnormal operating conditions, if the device is started up and fluoroscopy is performed immediately upon registration and inspection, it may cause the application to restart. Furthermore, after restarting, normal fluoroscopy and photography may not be possible.
- 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 Class II voluntary recall for its medical angiography X-ray machine (Registration Certificate No.: 20153302148), as reported by the National Medical Products Administration (NMPA) on January 14, 2019. This action, processed through the Shanghai Food and Drug Administration, addresses two significant product concerns. Firstly, in extremely rare circumstances, internal equipment noise could interfere with the synchronous transmission of image data, potentially compromising diagnostic image quality. Secondly, under abnormal operational scenarios, if fluoroscopy is performed immediately following equipment startup and the initiation of a registration inspection, the device's application may unexpectedly restart. This restart raises further concerns regarding the reliable performance of subsequent normal fluoroscopy and radiography procedures. The company’s voluntary recall aims to address these identified potential deficiencies to ensure the continued safety and efficacy of the medical device in clinical settings, adhering to the NMPA's regulatory framework for medical product oversight. This demonstrates the company's commitment to patient safety and product integrity.

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