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

Source: https://www.globalkeysolutions.net/records/china_product_recall/shenzhen-shentu-medical-imaging-equipment-co-ltd/0aed1648-1c3f-4968-8e0c-9f201920d968/
Source feed: China

> China NMPA product recall for Medical diagnostic X-ray machine by Shenzhen Shentu Medical Imaging Equipment Co., Ltd. published November 06, 2018. Recall level: Level 3. Shenzhen Shentu Medical Imaging Equipment Co., Ltd. initiated a voluntary Class III recall in Novemb

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shenzhen Shentu Medical Imaging Equipment Co., Ltd. voluntarily recalls medical diagnostic X-ray machines.
- Company Name: Shenzhen Shentu Medical Imaging Equipment Co., Ltd.
- Publication Date: 2018-11-06
- Product Name: Medical diagnostic X-ray machine
- Recall Level: Level 3
- Recall Reason: A recent internal audit revealed incomplete information regarding trademarks, product application scope, and usage environment in the existing instruction manual template. The product instruction manual has been revised and updated. While this does not affect normal customer use or product performance, Shenzhen Shentu Medical Imaging Equipment Co., Ltd. has initiated a recall due to non-compliance with relevant regulations.
- Discovering Company: Shenzhen Shentu Medical Imaging Equipment Co., Ltd.
- Manufacturing Company: Shenzhen Shentu Medical Imaging Equipment Co., Ltd.
- Summary: Shenzhen Shentu Medical Imaging Equipment Co., Ltd. initiated a voluntary Class III recall in November 2018 for 26 units of their Medical Diagnostic X-ray Machines, specifically model SONTU100-DRF. This action stemmed from an internal audit conducted around that time, which uncovered critical omissions and incomplete information within the product's instruction manual template. The identified issues included insufficient descriptions pertaining to trademarks, the product's intended scope, and its appropriate usage environment. The recall operates under the regulatory guidance of China's National Medical Products Administration (NMPA), aligning with the standards for medical device registration and compliance. The company clarified that these manual discrepancies did not, in fact, negatively affect the product's performance or safety for routine customer use. As a required action, Shenzhen Shentu Medical Imaging Equipment Co., Ltd. is actively informing all affected customers about the issue and detailing how they can obtain the newly revised instruction manuals. It is important to note that this recall focuses solely on updating documentation and does not necessitate the physical return of the X-ray machines, which are confirmed to be safe and operational for continued use.

Company: https://www.globalkeysolutions.net/companies/shenzhen-shentu-medical-imaging-equipment-co-ltd/865bc7db-35c5-4074-9daa-ace781b57174/