China NMPA Product Recall - Medical diagnostic X-ray system

Beijing GE Healthcare Co., Ltd. has initiated a voluntary Class II recall for specific batches of its medical diagnostic X-ray systems, model XR 6000, under the oversight of the National Medical Products Administration (NMPA). Publicly announced on September 14, 2016, this action follows GE Healthcare's recent discovery of a potential risk where the horizontal X-ray tube arm could sag or slip. While no serious injuries have been reported to date, this malfunction could lead to hazardous incidents. The recall impacts 183 units globally, with 117 units identified by specific batch numbers sold within China. To address this safety concern, Beijing GE Healthcare Co., Ltd. is implementing corrective measures, including notifying all affected customers via email and deploying engineers to inspect the recalled products on-site. This proactive step aims to ensure the safe and reliable operation of the medical devices.