# China NMPA Product Recall - Diagnostic Ultrasound System

Source: https://www.globalkeysolutions.net/records/china_product_recall/ge-healthcare-systems-trade-development-shanghai-co-ltd/b945b60a-2795-4445-b0a6-49a99a40c07e/
Source feed: China

> China NMPA product recall for Diagnostic Ultrasound System by GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. published September 13, 2021. Recall level: Level 3. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level III recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd. is voluntarily recalling its Diagnostic Ultrasound System.
- Company Name: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Publication Date: 2021-09-13
- Product Name: Diagnostic Ultrasound System
- Recall Level: Level 3
- Recall Reason: The Vscan Extend ultrasound diagnostic instrument's main unit label only displays the IP protection rating information (IP33) of the main unit system, lacking the IP protection rating information (IPX7) of the probe, which does not meet the standard requirements for labeling.
- Discovering Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Manufacturing Company: GE Healthcare Systems Trade Development (Shanghai) Co., Ltd.
- Summary: GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its Diagnostic Ultrasound System (Registration Certificate No.: 20192060366), as announced on September 13, 2021, by the National Medical Products Administration (NMPA) and Shanghai Municipal Drug Administration. The recall stems from a labeling non-compliance on the Vscan Extend ultrasound diagnostic instrument. The main unit's label correctly displayed its IP protection rating (IP33) but failed to include the probe's IP protection rating (IPX7), which is a requirement that was not met. While this labeling issue is not linked to product safety, the company is undertaking this recall action to ensure full compliance with regulatory standards. The primary action required is to correct the deficient labels on the affected devices. Further specifics regarding the impacted product models, specifications, and batch numbers are detailed in the associated "Medical Device Recall Event Report Form."

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