# China NMPA Product Recall - X-ray computed tomography equipment, whole-body X-ray computed tomography spiral scanning device

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-shecheng-medical-devices-co-ltd/86a7bc8c-fa1e-40a1-93bb-c9a98765918f/
Source feed: China

> China NMPA product recall for X-ray computed tomography equipment, whole-body X-ray computed tomography spiral scanning device by Shanghai Shecheng Medical Devices Co., Ltd. published December 29, 2016. Recall level: Level III. Shanghai Siemens Medical Devices Co., Ltd. issued a voluntary Level III recall for several models of

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Siemens Medical Devices Co., Ltd. has initiated a voluntary recall of X-ray computed tomography (CT) equipment and whole-body X-ray computed tomography spiral scanning devices.
- Company Name: Shanghai Shecheng Medical Devices Co., Ltd.
- Publication Date: 2016-12-29
- Product Name: X-ray computed tomography equipment, whole-body X-ray computed tomography spiral scanning device
- Recall Level: Level III
- Recall Reason: The company discovered that the residual current device (RCD) in the product's power distribution cabinet may be faulty, causing equipment interruption during patient scanning and delaying patient diagnosis. If faulty, the machine may trip during use. In the extremely rare event of a tripping during patient scanning, the power distribution cabinet (LCB) needs to be restarted, and the patient may need to be rescanned.
- Discovering Company: Shanghai Siemens Medical Devices Co., Ltd.
- Manufacturing Company: Shanghai Shecheng Medical Devices Co., Ltd.
- Summary: Shanghai Siemens Medical Devices Co., Ltd. issued a voluntary Level III recall for several models of its X-ray Computed Tomography Equipment and Whole-Body X-ray Computed Tomography Spiral Scanning Devices. Reported on November 25, 2016, and published by the National Medical Products Administration (NMPA) on December 29, 2016, the recall addresses a critical product issue. The company discovered that the residual current device (RCD) in the power distribution cabinet of the affected products could be damaged. This defect poses a risk of equipment interruption during patient scanning, potentially delaying diagnosis or requiring a re-scan. The regulatory framework for this action falls under the NMPA (formerly CFDA), with a Level III classification indicating a low probability of adverse health consequences. To resolve the issue, Siemens committed to providing on-site safety notices to customers of the 18 affected products in China. These notices will detail the potential risks and the company's corrective plan. The required action involves replacing the potentially problematic parts to ensure the reliable and safe operation of the medical imaging devices, thereby mitigating patient inconvenience and upholding product safety standards.

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