# China NMPA Product Recall - Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-china-co-ltd/6cafdffd-41d9-4ed1-a709-892a239ed060/
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System by GE Healthcare (China) Co., Ltd. published March 11, 2015. Recall level: Level I. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated an urgent, upgraded Level I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. updates voluntary recall information for MRI systems.
- Company Name: GE Healthcare (China) Co., Ltd.
- Publication Date: 2015-03-11
- Product Name: Magnetic Resonance Imaging System
- Recall Level: Level I
- Recall Reason: GE Healthcare has been informed that in some locations, the MRU (Magnetic Quench Unit) may not be connected to the magnet. If the MRU is disconnected, it will not function as intended and will fail to quench the magnet when the user presses the button.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare (China) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated an urgent, upgraded Level I recall for its Magnetic Resonance Imaging (MRI) Systems, as reported by the National Medical Products Administration (NMPA) on March 11, 2015. The recall, initially reported by the company on February 25th, stems from a critical product defect. The primary issue involves the Magnetic Trigger Unit (MRU) potentially disconnecting from the magnet. If disconnected, the MRU fails to perform its intended function of quenching the magnet when activated, posing a significant risk of serious injury or death to users. The recall initially impacted 1195 units, which was subsequently updated to include 1196 affected products across various models and specifications, with a global reach including China, the United States, and the European Economic Area. Under the NMPA's regulatory oversight for medical devices, GE Healthcare outlined two main corrective actions. Firstly, customers were to receive email communications detailing the issue and guiding them through self-checks on their systems. Any detected abnormalities required immediate cessation of use and contact with a GE Healthcare representative. Secondly, the company committed to deploying engineers to affected sites to conduct thorough inspections and implement necessary corrections to ensure product safety and compliance.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-china-co-ltd/54e52bc9-beef-4ac4-a7d7-a5f2c9dbe214/