China NMPA Product Recall - Ultrasound diagnostic system

Siemens Healthineers has initiated a voluntary Class II recall for its ultrasound diagnostic systems, as reported by the National Medical Products Administration (NMPA) on January 28, 2022. The recall stems from a discovered issue where affected ultrasound systems may display a 'disk full error,' which subsequently prevents the normal operation of clipping and storage functions. This issue impacts specific models, specifications, and batches of the manufactured ultrasound diagnostic system (Registration Certificate No.: 国械注进20192060016), with detailed information available in the accompanying 'Medical Device Recall Event Report Form.' The company is proactively addressing this potential problem to ensure product reliability and patient safety. This action aligns with the NMPA's regulatory framework for medical device safety, requiring companies to recall products posing a moderate risk to health.