# China NMPA Product Recall - Whole-body X-ray computed tomography system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/8a66ce45-fa48-420c-b31b-1fb76d452481/
Source feed: China

> China NMPA product recall for Whole-body X-ray computed tomography system by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published July 08, 2019. Recall level: Level 3 Recall. On July 8, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntar

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. is voluntarily recalling its whole-body X-ray computed tomography (CT) system.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-07-08
- Product Name: Whole-body X-ray computed tomography system
- Recall Level: Level 3 Recall
- Recall Reason: Some Revolution CT scanners have a potential problem that could result in additional low-dose radiation exposure.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On July 8, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its whole-body X-ray computed tomography system, specifically certain Revolution CT scanning equipment. This action was taken due to a potential problem that could lead to additional low-dose radiation exposure for patients. The National Medical Products Administration (NMPA) oversaw this regulatory action, which was also reported to the Shanghai Food and Drug Administration under Medical Device Registration Certificate No. 2019-160. While specific inspection dates were not detailed, the company proactively reported the defect. The core issue involves a potential malfunction within the CT scanning equipment, which could result in unintended radiation exposure beyond standard levels. As a Class III recall, the regulatory framework signifies that the identified issue is unlikely to cause severe adverse health consequences. The required action involves the company actively removing the affected products from use to mitigate any potential risks to patients and ensure device safety. Further specifics on affected models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/