# China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-vingmed-ultrasound-as/30063d24-f1da-4799-aaf1-0a5f01a2d82e/
Source feed: China

> China NMPA product recall for Color Doppler Ultrasound Diagnostic Instrument by GE Vingmed Ultrasound AS published May 02, 2017. Recall level: . GE Vingmed Ultrasound AS, through its China distributor GE Healthcare Systems Trading Development (S

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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 discovered that if the DICOM worklist system is slow to respond during searches, operators may select the wrong patient, resulting in incorrect patient information being displayed on the screen during ultrasound scans. This issue 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 problem.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Vingmed Ultrasound AS
- Summary: GE Vingmed Ultrasound AS, through its China distributor GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., has initiated a voluntary recall of its Color Doppler Ultrasound Diagnostic Instruments, specifically models Vivid E95, Vivid E90, and Vivid E80. The National Medical Products Administration (NMPA) published this recall notice on May 2, 2017.The primary issue identified is a software-related problem within the DICOM worklist system. If the system is slow to respond during patient searches, operators may inadvertently select the wrong patient, leading to incorrect patient information displayed during an ultrasound scan. This error could result in images being stored under the wrong patient's name, potentially causing a misdiagnosis. No patient injuries have been reported due to this issue.Under the NMPA's regulatory framework, the recall was reported, with an internal recall number FMI 76164. Despite the global recall, GE Healthcare confirmed that the specific affected batches of these ultrasound systems were neither imported into nor sold within China. Consequently, no direct product retrieval actions are required for Chinese markets for these specific batches. The NMPA's role involves requesting provincial Food and Drug Administrations to enhance their oversight and management of such products to prevent similar issues in the future.

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