China NMPA Product Recall - Radiotherapy planning system

Elekta (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class II recall for its radiotherapy planning system, as reported by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration (SFDA) on September 11, 2019. The recall addresses a critical software anomaly: when users employ the MU or dose-weighted mode for 3D plan generation, and subsequently change the number of treatment sessions, recalibrate the plan, and alter the wedge angle, the system may produce an incorrect machine jump count. This calculation error has the potential to compromise treatment accuracy.

In response to this safety concern, Elekta (Shanghai) Medical Devices Co., Ltd. is issuing safety notices to affected users. The company strongly recommends that all users consistently perform independent dose calculation checks and auxiliary MU checks prior to any treatment. Additionally, to mitigate the identified risk, users are advised to force the Monaco system to recalculate whenever the wedge angle is adjusted. This proactive measure aims to ensure patient safety and maintain the integrity of radiotherapy planning. Detailed information regarding affected product models, specifications, and batches is provided in the accompanying Medical Device Recall Event Report Form.