China NMPA Product Recall - Tumor Information Management System

The National Medical Products Administration (NMPA) announced a Class III voluntary recall by IMPAC Medical System, Inc., for its Tumor Information Management System (Registration Certificate No.: 20173700587). The recall, reported by its agent Elekta (Shanghai) Medical Device Co., Ltd., was published on September 13, 2017, stemming from a report dated July 21, 2017. The primary issue involves the linear accelerator's treatment bed moving in the reverse vertical direction. This critical malfunction, identified through user feedback from Germany, occurs specifically when utilizing the Bed Movement Assistant (CMA) software on remotely installed MOSAIQ products for vertical movement. This reverse motion can lead to incorrect patient positioning during radiotherapy or chemotherapy, posing a risk of inappropriate treatment. The manufacturer determined that incorrect input or unrecognized errors in bed position coordinate values within the Machine Characteristics Document (MAC), if undetected before clinical use, contribute to this positioning error. IMPAC Medical System, Inc. initiated a global recall to address this potential hazard. However, it's noteworthy that products sold and installed in China are explicitly exempt from this recall. This exemption is due to China's stringent installation procedures, which include mandatory field installation and verification for all MOSAIQ products, thereby mitigating the identified risks within the region. Therefore, no corrective actions are required for devices within China.