# 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/bbc68af8-6fef-429a-947e-3cea274dff72/
Source feed: China

> China NMPA product recall for Medical diagnostic X-ray machine by Shenzhen Shentu Medical Imaging Equipment Co., Ltd. published November 17, 2018. Recall level: Level 3 Recall. Shenzhen Shentu Medical Imaging Equipment Co., Ltd. initiated a voluntary Class III recall for 26 un

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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: 2018-11-17
- Product Name: Medical diagnostic X-ray machine
- Recall Level: Level 3 Recall
- Recall Reason: The instruction manual template contains incomplete descriptions of information such as trademarks, product application scope, and usage environment, which does not comply 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 for 26 units of its SONTU100-DRF medical diagnostic X-ray machines in China. This action, reported on November 1, 2018, and publicized by the National Medical Products Administration (NMPA) on November 17, 2018, resulted from an internal audit. The audit revealed that the product's instruction manual template contained incomplete information regarding trademarks, product scope, and usage environment. While the identified issue did not impact the normal operation or performance of the X-ray machines, the company proceeded with the recall to address non-compliance with relevant medical device regulatory documentation standards. The required action involves notifying all affected customers through follow-up communications to provide them with updated instruction manuals. There is no physical product recall as the devices remain fully functional and in normal working order, focusing solely on correcting the documentation deficiency.

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