# China NMPA Product Recall - Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/622426fa-fa57-4fec-ac50-e6a5e9f5bc4f
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published January 17, 2020. Recall level: Level 2. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level II recall

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling its Magnetic Resonance Imaging System.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2020-01-17
- Product Name: Magnetic Resonance Imaging System
- Recall Level: Level 2
- Recall Reason: GE Healthcare recently discovered that some MR systems may have incorrect date settings, which could lead to inaccurate dates recorded on images.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its Magnetic Resonance Imaging (MRI) System on January 17, 2020. The company identified an issue where certain MR systems might incorrectly set dates, potentially leading to inaccurate date information being recorded on medical images. This recall was reported to the National Medical Products Administration (NMPA) in China. The company's proactive measure addresses a potential data integrity concern, ensuring the reliability of date stamps on diagnostic images. The specific models, specifications, and batch numbers affected are detailed in the accompanying Medical Device Recall Event Report Form, which prompted the public notification by the Shanghai Municipal Drug Administration.

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