# China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-vingmed-ultrasound-as/b32706b3-f6e1-492c-b96d-03fa60aea00b/
Source feed: China

> China NMPA product recall for Color Doppler Ultrasound Diagnostic Instrument by GE Vingmed Ultrasound AS published April 27, 2017. Recall level: . The National Medical Products Administration (NMPA) issued a recall notice on April 27, 2017, regard

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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: 2017-04-27
- 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 incorrect information after the scan, the image 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) issued a recall notice on April 27, 2017, regarding Color Doppler Ultrasound Diagnostic Instruments, specifically Vivid E95, E90, and E80 models. The recall was voluntarily initiated by the manufacturer, GE Vingmed Ultrasound AS, with its Chinese distributor, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., reporting the issue on April 14, 2017. The primary concern is a software flaw where a slow DICOM worklist system response can cause operators to inadvertently select and store ultrasound images under incorrect patient information. This error could potentially lead to misdiagnosis. However, the manufacturer confirmed that the affected product batches were not imported or sold within China. Despite no reported injuries, the NMPA mandates ongoing supervision and management of this product, ensuring compliance with regulatory standards, particularly given the potential for misdiagnosis in other affected regions like the USA, Canada, and the European Economic Area.

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