China NMPA Product Recall - Radiotherapy patient positioning system

On September 10, 2019, Elekta (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall of its radiotherapy patient positioning system. The recall was prompted by an identified issue where the iGUIDE tracking system correlation check (CCC) could be overly sensitive under specific circumstances, potentially leading to erroneous requests for verification scans. This problem primarily occurs when the HexaPOD component cannot independently reach the target position and requires support from the Precise Treatment Table. The company reported this issue to the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. To address this, Elekta (Shanghai) Medical Devices Co., Ltd. is issuing safety notices to users and providing operational solutions aimed at preventing these unnecessary verification scan requests. The company emphasized that the issue is unlikely to occur and only under the specific conditions outlined. Further details regarding affected product models and batch numbers are available in the accompanying "Medical Device Recall Event Report Form".