China NMPA Product Recall - Ultrasound diagnostic instrument

On March 1, 2021, Esaote S.P.A., through its agent Esaote (Shenzhen) Medical Equipment Co., Ltd., announced a voluntary Class II recall of certain ultrasound diagnostic instruments. This action was prompted by a report from a magnetic field generator supplier, indicating that components manufactured within a specific timeframe possess insufficient measurement accuracy. The identified issue specifically impacts the performance of 3D fusion imaging, virtual navigation, and virtual puncture functions within the affected ultrasound devices. Consequently, this deficiency could compromise the accuracy of imaging results and guidance during subcutaneous puncture procedures, potentially affecting patient safety and treatment efficacy. Operating under the oversight of the National Medical Products Administration (NMPA), Esaote S.P.A. initiated this recall to address the identified product deficiency. The company is committed to ensuring the safety and reliability of its medical devices. Detailed information regarding the specific models, specifications, and affected batches of the ultrasound diagnostic instruments is provided in the "Medical Device Recall Event Report Form" attached to the official NMPA notice. This proactive recall demonstrates the company's commitment to regulatory compliance and patient well-being.