# China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-vingmed-ultrasound-as/c0f31eb5-5963-4d6c-af4d-f977ae46e071/
Source feed: China

> China NMPA product recall for Color Doppler Ultrasound Diagnostic Instrument by GE Vingmed Ultrasound AS published December 12, 2013. Recall level: . The National Medical Products Administration (NMPA) issued a recall notice on December 12, 2013, reg

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Vingmed Ultrasound AS is recalling color ultrasound diagnostic equipment.
- Company Name: GE Vingmed Ultrasound AS
- Publication Date: 2013-12-12
- Product Name: Color Doppler Ultrasound Diagnostic Instrument
- Recall Reason: The system's keyboard response time may increase, and may even cause the system to lock.
- 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 December 12, 2013, regarding GE Vingmed Ultrasound AS. GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. reported a voluntary global recall of GE Vingmed Ultrasound AS's color doppler ultrasound diagnostic instruments (Model: Vivid E9). The core issue identified was the potential for increased keyboard response times, which could lead to the system locking during clinical diagnostic examinations. The recall was initiated by the manufacturer, with the report date being November 26, 2013. Although the recall is global, the specific affected batches of these instruments were not sold within China. Therefore, no direct product retrieval or modification actions were required for the Chinese market. Nevertheless, the NMPA mandated that food and drug administration departments across all provinces, autonomous regions, and municipalities ensure the continued supervision and management of such products. GE Vingmed Ultrasound AS implemented a corrective action referred to as TEMS to address these technical deficiencies, demonstrating a proactive approach under regulatory oversight to mitigate potential operational disruptions.

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