China NMPA Product Recall - Diagnostic Ultrasound System

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."