# 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/d35e3172-be6e-4e3b-ae07-9b6ee542bee5/
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published December 06, 2018. Recall level: Level 2. On December 6, 2018, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a volu

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is voluntarily recalling Magnetic Resonance Imaging Systems (MRAs).
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2018-12-06
- Product Name: Magnetic Resonance Imaging System
- Recall Level: Level 2
- Recall Reason: This involves issues such as the product not reinstalling the latest field software version after performing service activities that require software reloading in certain work environments.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On December 6, 2018, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its magnetic resonance imaging (MRI) systems. This action was announced by the National Medical Products Administration (NMPA) under Index No. JGXX-2018-11431. The recall stems from a critical issue where the latest field software version was not consistently reinstalled on certain products following service activities that necessitated software reloading. The affected MRI systems are covered by Medical Device Registration Certificate Nos. CFDA (Imported) 2007 No. 3281719 and CFDA (Imported) 2011 No. 3282957. While specific models, specifications, and batches are detailed in an attached "Medical Device Recall Event Report Form," the core issue highlights a deviation in post-service software management protocols. This voluntary recall underscores the company's commitment to product safety and compliance with regulatory standards set by the NMPA and the Shanghai Food and Drug Administration. The required action involves removing affected devices from circulation or implementing corrective measures to ensure all systems are operating with the most current and validated software, thereby mitigating potential risks to patient safety and diagnostic accuracy.

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