China NMPA Product Recall - Image archiving and transmission system

The National Medical Products Administration (NMPA) issued a notice on September 7, 2015, regarding a voluntary recall initiated by GE Healthcare for its Image Archiving and Transmission Systems. GE Healthcare Trading Development (Shanghai) Co., Ltd. reported the recall of specific models, including the Centricity Universal Viewer, Version 5.0 (and earlier patches). The primary issue identified was a software defect where, if the system parameter "MapRoute" was set above 1, the system might fail to process all images during an examination, leading to missing images. Fortunately, no patient injuries related to this defect have been reported. This recall falls under the regulatory purview of the NMPA in China. A key aspect of this recall is that, despite the product holding a CFDA (now NMPA) registration certificate, all affected batches of the Image Archiving and Transmission Systems were not sold within the Chinese market, with distribution concentrated in regions such as the United States and the European Economic Area. Consequently, no direct corrective actions were necessary for products within China. However, the NMPA requested that all relevant provincial and municipal food and drug administrations enhance their oversight and management of similar medical imaging products. The initial recall report was submitted on August 11, 2015.