# China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-vingmed-ultrasound-as/9017f6d6-5868-4157-b1e7-12d8c6eedadb/
Source feed: China

> China NMPA product recall for Color Doppler Ultrasound Diagnostic Instrument by GE Vingmed Ultrasound AS published April 28, 2017. Recall level: . GE Vingmed Ultrasound AS, the manufacturer, and its Chinese distributor, GE Healthcare Systems Tradi

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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: 2017-04-28
- 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: GE Vingmed Ultrasound AS, the manufacturer, and its Chinese distributor, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., initiated a voluntary recall, indexed as FMI 76164. The National Medical Products Administration (NMPA) published this recall notice (JGXX-2017-10342) on April 28, 2017, based on a report from the Chinese distributor dated April 14, 2017. The recall concerns Color Doppler Ultrasound Diagnostic Instruments, including models Vivid E95, Vivid E90, and Vivid E80, holding Registration Certificate No.: 20173230626. The central issue stems from a potential malfunction in the DICOM worklist system. If this system responds slowly during patient searches, operators might inadvertently select an incorrect patient. This could lead to erroneous patient information being displayed during ultrasound examinations. If not rectified, images could be stored under the wrong 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Company: https://www.globalkeysolutions.net/companies/ge-vingmed-ultrasound-as/9b912706-d8b0-4297-9708-c09cba00232e/