China NMPA Product Recall - Picture Archiving and Communication System

GE Healthcare, through its agent GE Healthcare Trading Development (Shanghai) Co., Ltd., voluntarily reported two Class II recalls concerning its Picture Archiving and Communication System (Centricity Universal Viewer Release Version 6.0) to the National Medical Products Administration (NMPA) of China. The first report, dated January 8, 2019, detailed a software issue (FMI85448) where image modification activities could lead to desynchronization of patient context information between the Universal Viewer and other workstations. This could result in patient data being incorrectly linked to images. The second report, from October 24, 2018, described another software problem (FMI85444) where remote images retrieved from third-party DICOM systems for cross-enterprise comparison might be associated with the wrong patient without a warning. Both issues have not resulted in any reported injuries. Under the NMPA's regulatory framework for medical devices, GE Healthcare identified these potential risks. Despite the recall level, no affected product batches were sold within China. Consequently, the required action for the Chinese market was limited to reporting the incidents to the NMPA, as no direct consumer impact or product retrieval was necessary domestically. GE Healthcare indicated plans to correct all affected systems globally.