China NMPA Product Recall - Image archiving and transmission system

On September 29, 2015, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd., under the regulatory oversight of the National Medical Products Administration (NMPA), initiated a voluntary Class II recall for its Centricity Universal Viewer Image Archiving and Transmission Systems, Version 5.0 (SP2 and above). The recall affects five units sold in China, with affected regions including the United States, European Economic Area, Canada, and China. The core issue involves a software defect causing inaccurate distance measurements in magnified views of medical images, specifically X-ray and fluoroscopic projections. This occurs because the Universal Viewer software fails to properly account for the magnification factor generated by certain digital X-ray systems during image acquisition and processing. Consequently, distance measurements may be overestimated if a known reference size is unavailable or manual calibration is not performed. Although no patient injuries have been reported, this defect poses a potential risk for clinical misinterpretation. In response, GE Healthcare committed to two primary corrective actions. First, the company distributed a customer notification letter to inform users of the identified issue and provide essential guidance for safe product use. Second, GE Healthcare will deploy a software upgrade designed to fully rectify the calculation error, thereby ensuring accurate distance measurements in all compatible imaging scenarios. These actions aim to mitigate risks and restore confidence in the system's precision.