# China NMPA Product Recall - Magnetic resonance imaging system; Positron emission tomography (PET) system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/a47ab2e8-5de2-4f20-b28f-95db600ccefb/
Source feed: China

> China NMPA product recall for Magnetic resonance imaging system; Positron emission tomography (PET) system by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published December 16, 2019. Recall level: Level 2 Recall. On December 16, 2019, GE Healthcare Trading Development (Shanghai) Co., Ltd. initiated a voluntary C

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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 (MRI) systems.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-12-16
- Product Name: Magnetic resonance imaging system; Positron emission tomography (PET) system
- Recall Level: Level 2 Recall
- Recall Reason: GE Healthcare recently discovered that certain main switch panels (MDPs) from select third-party vendors may not conform to GE Healthcare's pre-installation specifications. When the emergency shutdown (E-Off) circuit is activated, the MDP does not cut off power to the heat exchanger cabinet (HEC).
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On December 16, 2019, GE Healthcare Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Magnetic Resonance Imaging (MRI) Systems and Positron Emission Magnetic Resonance Imaging Systems. This action was prompted by recent findings that specific master switch panels (MDPs), sourced from third-party suppliers, did not meet GE Healthcare’s pre-installation quality standards. The critical issue identified is the failure of these MDPs to disconnect power to the Heat Exchanger Cabinet (HEC) when the Emergency Off (E-Off) circuit is activated, posing a potential safety risk. This recall falls under the regulatory oversight of the National Medical Products Administration (NMPA). GE Healthcare is taking corrective measures by voluntarily recalling the affected medical devices to ensure patient safety and product integrity. Further details regarding the specific models, specifications, and batches involved are outlined in the "Medical Device Recall Event Report Form".

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