# China NMPA Product Recall - Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-china-co-ltd/3e00f5a4-267c-4345-b56b-758b40192904/
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System by GE Healthcare (China) Co., Ltd. published September 02, 2015. Recall level: Level 3 Recall. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. voluntarily recalls magnetic resonance imaging systems.
- Company Name: GE Healthcare (China) Co., Ltd.
- Publication Date: 2015-09-02
- Product Name: Magnetic Resonance Imaging System
- Recall Level: Level 3 Recall
- Recall Reason: When using a whole-body coil to scan a patient's head and neck, the actual specific absorption rate (SAR value) may be higher than the displayed value, which could lead to deep tissue burns.
- 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 a voluntary Class III recall of various Magnetic Resonance Imaging (MRI) Systems on September 2, 2015, under the regulatory framework of the National Medical Products Administration (NMPA). The recall stemmed from an internal finding that when whole-body coils were utilized for head and neck scans, the actual Specific Absorption Rate (SAR) values could exceed the displayed figures. This discrepancy presented a potential risk of deep tissue burns, although no related adverse events or patient complaints had been reported. Computer model calculations confirmed that SAR monitoring values might be marginally lower than actual values. The recall impacted 288 units sold in China, in addition to products in the United States, European Economic Area, and Canada. Required actions included informing customers about the issue and providing guidance on safe operation. Furthermore, GE Healthcare dispatched engineers to perform free on-site corrections for all affected MRI systems, ensuring patient safety and device accuracy.

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