China NMPA Product Recall - Portable color ultrasound diagnostic instrument

Fujifilm (China) Investment Co., Ltd. initiated a voluntary Class III recall of certain portable color ultrasound diagnostic instruments, as reported on December 5, 2018. The recall was prompted by the discovery of incorrect labeling on specific batches of these medical devices. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) of China. The company's proactive measure addresses the labeling discrepancy to ensure compliance and product integrity. Detailed information regarding the affected product models and specific recall levels is outlined in the accompanying "Medical Device Recall Event Report Form" and related attachments. This recall underscores the importance of accurate product information and adherence to established regulatory standards for medical devices within the Chinese market.