# China NMPA Product Recall - Digital medical X-ray imaging system

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-shecheng-medical-devices-co-ltd/cb1653fe-4b4a-4861-a051-1ef38ed888f7/
Source feed: China

> China NMPA product recall for Digital medical X-ray imaging system by Shanghai Shecheng Medical Devices Co., Ltd. published September 29, 2016. Recall level: Level III. Shanghai Siemens Healthineers Co., Ltd. has initiated a voluntary recall of specific Digital Medical

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Siemens Healthineers Co., Ltd. voluntarily recalls digital medical X-ray imaging systems
- Company Name: Shanghai Shecheng Medical Devices Co., Ltd.
- Publication Date: 2016-09-29
- Product Name: Digital medical X-ray imaging system
- Recall Level: Level III
- Recall Reason: During the assembly process of some hospital beds, an engineer failed to install the limit ring, resulting in an error.
- Discovering Company: Shanghai Siemens Healthineers Co., Ltd.
- Manufacturing Company: Shanghai Shecheng Medical Devices Co., Ltd.
- Summary: Shanghai Siemens Healthineers Co., Ltd. has initiated a voluntary recall of specific Digital Medical X-ray Imaging Systems, as reported by the National Medical Products Administration (NMPA) on September 29, 2016. The recall, detailed in a report dated August 2, 2016, addresses a critical manufacturing defect: the omission of a limit ring from a bed component on affected units. This oversight presents a significant safety concern, as it could potentially lead to patients slipping off the examination bed during use. The recall involves eight units, specifically Multix Fusion New Tianlong and Multix Fusion Yilong models, all distributed within China. This regulatory action falls under the purview of the NMPA and the Shanghai Food and Drug Administration. In response, Shanghai Siemens Healthineers has outlined a three-pronged corrective strategy. This includes sending safety advisory notices to all customers with potentially affected products, dispatching service engineers for on-site inspection of each of the eight units to confirm the missing component, and subsequently implementing appropriate corrective measures to resolve the safety issue once confirmed.

Company: https://www.globalkeysolutions.net/companies/shanghai-shecheng-medical-devices-co-ltd/2362619d-a99a-4cb8-a699-ecc57bae22c0/