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

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-medical-systems-llc/c9b6e529-7b2a-4b55-86ac-3f91ef0d3e76/
Source feed: China

> China NMPA product recall for Whole-body X-ray computed tomography system by GE Medical Systems, LLC published May 08, 2015. Recall level: . GE Medical Systems, LLC initiated a voluntary recall of its whole-body X-ray computed tomography sys

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Medical Systems, LLC is recalling its whole-body X-ray computed tomography (CT) system.
- Company Name: GE Medical Systems, LLC
- Publication Date: 2015-05-08
- Product Name: Whole-body X-ray computed tomography system
- Recall Reason: The engineer failed to perform the required torque fixation repeat test on the three fixed points of C].
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Medical Systems, LLC
- Summary: GE Medical Systems, LLC initiated a voluntary recall of its whole-body X-ray computed tomography system, as reported by GE Medical Systems Trading Development (Shanghai) Co., Ltd. The recall, announced by the National Medical Products Administration (NMPA) on May 8, 2015, stemmed from a critical manufacturing oversight. Engineers failed to perform the necessary torque fixation repeat test on three specific fixation points within the medical device. Although the manufacturer issued this recall, the company confirmed that the affected products were not distributed or sold within the Chinese market. In response to this event, the NMPA instructed provincial and autonomous regional food and drug administrations to enhance their oversight and management of similar medical products to ensure public safety and compliance with regulatory standards.

Company: https://www.globalkeysolutions.net/companies/ge-medical-systems-llc/f2726879-5e5f-418f-9650-23534a1a0bd5/