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

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/0b4a4b9c-7355-4404-988c-0d29bad2ca46/
Source feed: China

> China NMPA product recall for Medical angiography X-ray machine by Siemens Healthineers Co., Ltd. published October 18, 2021. Recall level: Level 2. On October 18, 2021, Siemens Healthineers initiated a voluntary Level II recall of specific medical 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers has initiated a voluntary recall of its medical angiography X-ray machines.
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2021-10-18
- Product Name: Medical angiography X-ray machine
- Recall Level: Level 2
- Recall Reason: Siemens has identified four potential problems with the ARTIS icono and ARTIS pheno systems with software version VE20C.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: On October 18, 2021, Siemens Healthineers initiated a voluntary Level II recall of specific medical angiography X-ray machines, encompassing models from its ARTIS icono and ARTIS Pheno product lines. This action was publicly announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration Website in China. The company’s decision to recall these devices stemmed from the discovery of four potential issues associated with the Pheno system, affecting machines identified by registration certificate numbers such as 20213060262, 20213060323, and 20183300137. While the precise details of these issues were not elaborated in the public notice, the Level II classification signifies that the issues could lead to temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. The regulatory framework overseeing this recall is provided by the NMPA, which is responsible for ensuring medical device safety and compliance in China. As a key required action, Siemens Healthineers is obligated to furnish comprehensive information regarding the affected product models, specifications, and batches through an official "Medical Device Recall Event Report Form." This proactive measure underscores the company's commitment to product safety and adherence to regulatory standards.

Company: https://www.globalkeysolutions.net/companies/siemens-healthineers-co-ltd/92a17b04-898c-4eba-81aa-91900b470181/