China NMPA Product Recall - Ultrasound diagnostic system

On March 2, 2021, Siemens Healthineers initiated a voluntary Class II recall for its ACUSON Sequoia ultrasound diagnostic system, specifically those utilizing VA11A software. This action, reported under the National Medical Products Administration (NMPA) and sourced from the Shanghai Municipal Drug Administration, addresses a significant safety concern. The primary issue identified is the potential for the affected ultrasound systems to generate an incorrect Estimated Due Date (EDD). This inaccuracy stems from the software's inclusion of both the average mean gestational sac diameter (MSD) and the gestational sac diameter (GSD) in its EDD calculations. Consequently, healthcare professionals relying on these measurements could receive erroneous due date estimates, potentially impacting patient management. Siemens Healthineers proactively implemented this voluntary recall, identified by Registration Certificate No.: 国械注进20192060012, to mitigate this risk. Comprehensive details regarding the specific product models, specifications, and involved batches are provided in the accompanying 'Medical Device Recall Event Report Form.'