# China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

Source: https://www.keypedia.com/records/china_product_recall/ge-vingmed-ultrasound-as/f1d7ac17-b99b-48d9-aa7a-7f9cffd4fe92
Source feed: China

> China NMPA product recall for Color Doppler Ultrasound Diagnostic Instrument by GE Vingmed Ultrasound AS published May 02, 2017. Recall level: . The National Medical Products Administration (NMPA) published a recall notice on May 2, 2017, concer

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Vingmed Ultrasound AS recalls color ultrasound diagnostic equipment
- Company Name: GE Vingmed Ultrasound AS
- Publication Date: 2017-05-02
- Product Name: Color Doppler Ultrasound Diagnostic Instrument
- Recall Reason: GE Healthcare has discovered that if the DICOM worklist system is slow to respond during searches, operators may select the wrong patient. Incorrect patient information will appear on the screen during ultrasound scans; this only occurs with certain Vivid ultrasound systems. If the operator does not delete the image after the scan, it will be stored under the wrong patient's name (not the target patient). This could lead to misdiagnosis. No injuries have been reported as a result of this issue.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Vingmed Ultrasound AS
- Summary: The National Medical Products Administration (NMPA) published a recall notice on May 2, 2017, concerning Color Doppler Ultrasound Diagnostic Instruments manufactured by GE Vingmed Ultrasound AS. Distributed by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., the voluntary recall addresses a critical issue where operators using specific Vivid ultrasound systems (models E95, E90, E80) might select the wrong patient. This occurs when the DICOM worklist system responds slowly during searches, potentially displaying incorrect patient information during scans. If not rectified by the operator, images could be stored under the wrong patient's name, thereby creating a risk of misdiagnosis. Although no injuries have been reported, the NMPA framework prompted local food and drug administrations to enhance their management of similar products. Importantly, GE Healthcare confirmed that the affected batches of these ultrasound instruments were not sold in China. For further inquiries, stakeholders are directed to contact Wang Tong at GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.

Company: https://www.keypedia.com/companies/ge-vingmed-ultrasound-as/9b912706-d8b0-4297-9708-c09cba00232e