China NMPA Product Recall - Color Doppler Ultrasound Diagnostic Instrument

GE Ultrasound Korea, through its agent GE Healthcare Systems Trade Development (Shanghai) Co., Ltd., initiated a voluntary Class II recall of its color Doppler ultrasound diagnostic instruments. This action, reported to the National Medical Products Administration (NMPA) on March 12, 2019, and publicly announced on March 21, 2019, addresses a potential safety issue. The primary concern stems from a specific component failure that could lead to an increase in the probe surface temperature during use, particularly with the Logiq P5 model. This could pose a risk during human ultrasound diagnostic examinations. Despite holding NMPA Registration Certificate No. CFDA (Imported) 2007 No. 3230048, and not having received any market feedback, complaints, or adverse event reports in China, GE Healthcare proactively decided on the recall to uphold its high safety and quality standards. Although the affected product batches were not sold in China, the company fulfilled its regulatory obligations by reporting the incident to the NMPA and submitting a Medical Device Recall Event Report Form, demonstrating its commitment to patient safety and regulatory compliance.