# China NMPA Product Recall - Whole-body X-ray computed tomography spiral scanning device

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-shecheng-medical-devices-co-ltd/ee38c6bd-c5e4-4623-89e0-12387fcfc434/
Source feed: China

> China NMPA product recall for Whole-body X-ray computed tomography spiral scanning device by Shanghai Shecheng Medical Devices Co., Ltd. published June 02, 2015. Recall level: Level 3 Recall. Shanghai Siemens Medical Devices Co., Ltd. initiated a Level 3 voluntary recall on June 2, 2015, und

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Siemens Medical Devices Co., Ltd. has initiated a voluntary recall of its whole-body X-ray computed tomography spiral scanning device.
- Company Name: Shanghai Shecheng Medical Devices Co., Ltd.
- Publication Date: 2015-06-02
- Product Name: Whole-body X-ray computed tomography spiral scanning device
- Recall Level: Level 3 Recall
- Recall Reason: The customer noticed noise during machine use and notified the maintenance engineer. Upon inspection, the engineer discovered that two of the three bolts securing the counterweight were broken, and one was deformed. This caused the counterweight to loosen and collide with adjacent components, generating noise. No one was injured in the incident. The company investigated the incident and found that a flawed design in the bolt manufacturing process, as well as discrepancies between the raw materials and the drawings, could have led to bolt fatigue fracture. While a single broken bolt is not inherently dangerous, over time, in the extremely rare event that all three bolts may have broken undetected, the counterweight could detach and potentially slide out of the frame's window strip, potentially causing injury if a patient or equipment operator happened to be present.
- Discovering Company: Shanghai Siemens Medical Devices Co., Ltd.
- Manufacturing Company: Shanghai Shecheng Medical Devices Co., Ltd.
- Summary: Shanghai Siemens Medical Devices Co., Ltd. initiated a Level 3 voluntary recall on June 2, 2015, under the oversight of the National Medical Products Administration (NMPA), for its whole-body X-ray computed tomography spiral scanning devices, specifically the SOMATOM Emotion 6-slice and 16-slice configurations. The recall was prompted by the discovery of fatigue fracture in the bolts securing the balance block. This critical issue caused the balance block to loosen, collide with adjacent components, and generate noise. While no injuries were reported, the company identified a severe potential risk where undetected, complete bolt failure could lead to the balance block detaching and potentially injuring patients or equipment operators. An investigation by Shanghai Siemens Medical Devices Co., Ltd. traced the root cause to a flawed bolt manufacturing process design and deviations between raw materials and specified drawing requirements. In response, the company is issuing safety advisory notices to affected customers, detailing the risks and outlining the final corrective solution. This includes activating an on-site service for balance block bolt remediation. The recall impacts 214 products globally, with 41 units sold in China.

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