China NMPA Product Recall - Radiotherapy planning software

Elekta (Shanghai) Medical Devices Co., Ltd. initiated a voluntary Class III recall of its imported radiotherapy planning software, publicly announced by the National Medical Products Administration (NMPA) on September 22, 2021. The recall addresses a critical issue where, under specific user operational conditions, contour edits within the software could be erroneously saved to non-planned image sets. This defect poses a risk by potentially causing discrepancies between the initial reference treatment plan and the updated plan output for patients undergoing radiotherapy. The company proactively identified this concern and issued a global field safety notice for its software, which is an integral component of MRI-guided radiotherapy systems. In response, Elekta (Shanghai) Medical Devices Co., Ltd. is implementing on-site corrective actions for all affected products worldwide, demonstrating compliance with regulatory standards and a commitment to patient safety within the medical device industry.