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

Source: https://www.globalkeysolutions.net/records/china_product_recall/shimadzu-enterprise-management-china-co-ltd/ad861efd-3735-4a2f-8e12-44ce02eada26/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by Shimadzu Enterprise Management (China) Co., Ltd. published December 06, 2021. Recall level: Level 3 Recall. Shimadzu Enterprise Management (China) Co., Ltd. has initiated a voluntary Class III recall of its m

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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: 2021-12-06
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 3 Recall
- Recall Reason: There is a very small probability that the following situation may occur with this equipment: if the maximum dose rate is not confirmed strictly according to the manufacturer's commissioning procedures during equipment installation and commissioning, the irradiation dose rate may exceed the limit specified by the manufacturer when performing non-standard exposure procedures.
- Discovering Company: Shimadzu Enterprise Management (China) Co., Ltd.
- Manufacturing Company: Shimadzu Enterprise Management (China) Co., Ltd.
- Summary: Shimadzu Enterprise Management (China) Co., Ltd. has initiated a voluntary Class III recall of its medical angiography X-ray machines, as announced by the National Medical Products Administration (NMPA) on December 6, 2021. The recall addresses a critical safety concern: if the maximum dose rate is not strictly confirmed during installation and commissioning according to manufacturer procedures, there is a small probability the equipment's irradiation dose rate could exceed specified limits during non-standard exposure procedures. This presents a risk of unintended radiation exposure. The regulatory framework for this action falls under the NMPA, overseeing medical device safety in China. As a required action, Shimadzu is recalling affected product models, specifications, and batches, with detailed information available in the "Medical Device Recall Event Report Form." This proactive measure underscores the company's commitment to patient safety and regulatory compliance.

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