China NMPA Product Recall - Radiotherapy Clinical Management Software

Elekta Solutions AB, in cooperation with its subsidiary Elekta (Shanghai) Medical Devices Co., Ltd., has initiated a voluntary Class III recall of its radiotherapy clinical management software. This action, publicly reported on September 29, 2025, falls under the regulatory purview of the National Medical Products Administration (NMPA) of China. The recall addresses a critical issue where certain software products, identified by National Medical Device Registration Certificate No. 20173210587, may fail to adequately increase patient plans that incorporate rolling scheduling orders. The company's required action involves a complete voluntary recall of all affected software. Notably, the specific products subject to this recall were not imported into the Chinese market, indicating a proactive measure to prevent potential issues globally. Elekta's decision underscores a commitment to product integrity and patient safety by addressing a functional deficiency before wider distribution. Comprehensive details regarding the models, specifications, and batch numbers of the recalled radiotherapy software are provided within the "Medical Device Recall Event Attachment: Medical Device Recall Event Report Form." This official document ensures transparency and compliance with NMPA reporting standards, guiding stakeholders on the specifics of the recall event.