China NMPA Product Recall - Diagnostic Ultrasound System

Siemens Medical Solutions USA, Inc., under the regulatory oversight of the National Medical Products Administration (NMPA), announced on July 22, 2021, a voluntary Level II recall of specific models and batches of its Diagnostic Ultrasound System. The primary issue identified is a critical malfunction where certain systems, when equipped with an installed battery pack, may fail to start properly when not connected to an external power source. This operational defect could potentially impact the reliable use of the device in clinical settings, particularly where continuous external power may not be assured. The manufacturer, Siemens Medical Solutions USA, Inc., initiated this recall to address the performance anomaly in the Diagnostic Ultrasound System (Registration Certificate No.: 2019206001). Detailed information concerning the affected product models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form" attachment. This recall highlights the company's commitment to product safety and compliance with NMPA's regulatory framework, ensuring that healthcare providers can rely on the integrity of their diagnostic equipment.