# China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

Source: https://www.keypedia.com/records/china_product_recall/ge-vingmed-ultrasound-as/4a2d5d2f-00e9-4764-afc7-6caa0ec47250
Source feed: China

> China NMPA product recall for Color Doppler Ultrasound Diagnostic Instrument by GE Vingmed Ultrasound AS published April 27, 2017. Recall level: . This National Medical Products Administration (NMPA) document, published on April 27, 2017, details 

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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 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: This National Medical Products Administration (NMPA) document, published on April 27, 2017, details a voluntary product recall initiated by GE Vingmed Ultrasound AS, a manufacturer of medical devices. The recall was reported by GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., the responsible unit in China, on April 14, 2017.The recall pertains to certain Color Doppler Ultrasound Diagnostic Instruments, specifically the Vivid E95, Vivid E90, and Vivid E80 models. The primary issue identified is a software-related problem where a slow response from the DICOM worklist system can lead operators to inadvertently select incorrect patient information. This error could result in patient data being displayed inaccurately during ultrasound scans and, if not corrected, images being stored under the wrong patient's record. Such a flaw carries the risk of misdiagnosis.While the recall highlights a significant patient safety concern, the manufacturer confirmed that no injuries have been reported due to this specific issue. Crucially, the affected product batches were not sold within the Chinese market, limiting direct impact in the region. The NMPA's regulatory framework requires local food and drug administration departments to supervise and manage this product in accordance with relevant regulations, and provides contact information for any inquiries.

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