# China NMPA Product Recall - Automated breast ultrasound diagnostic system

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/2d32b57e-0195-4399-9375-ea93a3bed411/
Source feed: China

> China NMPA product recall for Automated breast ultrasound diagnostic system by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published April 11, 2019. Recall level: Level 3 Recall. On April 11, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a volunt

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. is voluntarily recalling its automated breast ultrasound diagnostic system.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2019-04-11
- Product Name: Automated breast ultrasound diagnostic system
- Recall Level: Level 3 Recall
- Recall Reason: The registered address on the product's Chinese label is incorrect.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: On April 11, 2019, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recall for its Automated Breast Ultrasound Diagnostic System. This action was overseen by the National Medical Products Administration (NMPA). The primary issue prompting the recall was an inaccuracy on the product's Chinese label, specifically an incorrect registrant's address. The affected product is registered under Certificate No. 国械注进20152230792. While specific inspection dates are not detailed, the recall announcement was publicly disclosed by the NMPA on the aforementioned date. This voluntary measure signifies the company's commitment to adhering to regulatory standards regarding medical device labeling and accuracy. As part of the required actions, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is obligated to provide detailed information on all affected models, specifications, and batches through a "Medical Device Recall Event Report Form." This ensures that all relevant parties are informed and appropriate corrective measures are implemented to rectify the labeling error, aligning with the regulatory framework governing medical devices in China.

Company: https://www.globalkeysolutions.net/companies/ge-healthcare-systems-trade-development-shanghai-co-ltd/4d6c1bd7-e2c1-400d-b03c-385df7470df5/