China NMPA Product Recall - Picture Archiving and Communication System

On December 10, 2021, the National Medical Products Administration (NMPA) announced that GE Healthcare Trading Development (Shanghai) Co., Ltd., on behalf of its manufacturer GE Healthcare, initiated a voluntary Level II recall of specific models and batches of its Picture Archiving and Communication System (PACS) software. This regulatory action falls under the NMPA's framework for medical device safety in China. The primary issue prompting the recall was a critical software malfunction identified within the inspection management function of the PACS software. This defect could potentially impact the system's ability to accurately perform or manage inspection-related tasks. A Level II recall indicates that the use of, or exposure to, the affected product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. As a required action, GE Healthcare is implementing this voluntary recall, with comprehensive details regarding the specific affected product models, specifications, and batches made available in an 'E-Recall Event Report Form' and an attached PDF document.