# China NMPA Product Recall - Magnetic Resonance Imaging System; Medical Magnetic Resonance Imaging System; Positron Emission Magnetic Resonance Imaging System

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/95626f83-1a3d-4ecd-9d20-103108d90549/
Source feed: China

> China NMPA product recall for Magnetic Resonance Imaging System; Medical Magnetic Resonance Imaging System; Positron Emission Magnetic Resonance Imaging System by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published July 14, 2021. Recall level: Level 2 Recall. On July 14, 2021, GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. initiated a voluntary

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is proactively recalling magnetic resonance imaging (MRI) systems.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2021-07-14
- Product Name: Magnetic Resonance Imaging System; Medical Magnetic Resonance Imaging System; Positron Emission Magnetic Resonance Imaging System
- Recall Level: Level 2 Recall
- Recall Reason: The product is subject to the risk of human error, meaning that when the "Save Rx" button is to be pressed, the "Patient Orientation" button may be pressed unintentionally, which may lead to incorrect labeling and/or image flipping.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On July 14, 2021, GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. initiated a voluntary Class II recall for multiple Magnetic Resonance Imaging (MRI) and Positron Emission Magnetic Resonance Imaging (PET-MRI) Systems. This action, mandated under the oversight of the National Medical Products Administration (NMPA), addresses a critical operational defect. The core issue involves the potential for the "Patient Orientation" button to be inadvertently activated when the "Rx" button is pressed during system operation. This design flaw could lead to incorrect image labeling or image flipping, raising concerns about diagnostic accuracy and patient safety. The recall covers a significant number of devices across various models, as indicated by numerous registration certificate numbers. While specific inspection dates are not detailed, the recall date signifies the company's prompt response to the identified problem. The required actions involve the voluntary recall of these affected medical devices, with comprehensive details on specific models, specifications, and batches, along with precise corrective steps, outlined in the accompanying "Medical Device Recall Event Report Form." This recall highlights the imperative for robust user interface design in complex medical equipment to mitigate potential errors and maintain data integrity.

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