# China NMPA Product Recall - Mobile C-arm X-ray machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/siemens-healthineers-co-ltd/9958614a-28f5-4ae2-8ac4-68cf624baeee/
Source feed: China

> China NMPA product recall for Mobile C-arm X-ray machine by Siemens Healthineers Co., Ltd. published March 26, 2019. Recall level: Level 2 Recall. On March 26, 2019, Siemens Healthineers announced a Class II voluntary recall of its mobile C-arm X-

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Siemens Healthineers has initiated a voluntary recall of its mobile C-arm X-ray machine.
- Company Name: Siemens Healthineers Co., Ltd.
- Publication Date: 2019-03-26
- Product Name: Mobile C-arm X-ray machine
- Recall Level: Level 2 Recall
- Recall Reason: The issue concerns the problem of premature wear and tear on the X-ray components caused by prolonged operation of the X-ray tube at high power output.
- Discovering Company: Siemens Healthineers Co., Ltd.
- Manufacturing Company: Siemens Healthineers Co., Ltd.
- Summary: On March 26, 2019, Siemens Healthineers announced a Class II voluntary recall of its mobile C-arm X-ray machines. This action was reported under the oversight of the National Medical Products Administration (NMPA), with the product also holding a medical device registration certificate from the Shanghai Food and Drug Administration. The primary issue identified was that under high power output conditions and prolonged operation, the X-ray tube in the product could experience rapid wear and tear within the X-ray assembly. This defect has the potential to impact the machine's performance and patient safety during diagnostic procedures. As a required action, Siemens Healthineers initiated this voluntary recall. A Class II recall indicates a situation where a product defect may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Comprehensive details regarding the affected models, specifications, and batch numbers are provided in an attached 'Medical Device Recall Event Report Form', ensuring transparency and guiding necessary actions for customers and regulatory bodies to address the identified product concern.

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