China NMPA Product Recall - Tumor Information Management System

Elekta, Inc. initiated a Class III voluntary recall of its Tumor Information Management System (MOSAIQ Oncology Information System), as reported to the National Medical Products Administration (NMPA) on November 18, 2019. The recall, stemming from a report on October 17, 2019, addresses a critical software issue where users might inadvertently enter vital sign data (height and weight) in metric units while the system defaults to US standard units. This discrepancy could lead to an incorrect and significantly overstated calculation of a patient's body surface area (BSA), potentially resulting in patients receiving a higher dose of chemotherapy than medically required. Elekta (Shanghai) Medical Device Co., Ltd. serves as the agent for this recalling unit. While this is a global recall, the associated risk does not affect products sold or installed in China. This is because the MOSAIQ chemotherapy module is not registered in China, and the specific process of entering patient height and weight that triggers this software issue is not applicable in Chinese clinical settings. Consequently, no specific actions are required for users within China. The recall aims to mitigate potential patient harm stemming from incorrect chemotherapy dosages due to miscalculated BSA in other affected regions globally.