China NMPA Product Recall - Radiation Treatment Planning System

Elekta, Inc. (USA), in conjunction with Elekta (Shanghai) Medical Device Co., Ltd., has initiated a voluntary Class III recall of its Radiation Treatment Planning Software (Registration Certificate No.: 20153210147). The recall was reported on August 6, 2021. The primary issue identified is that specific early versions of the software may exhibit calculation problems under certain usage scenarios, potentially affecting treatment planning accuracy. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) of China. As a required action, the company is recalling affected product models and batches to mitigate potential risks associated with the identified software anomaly. Detailed information regarding the affected products is available in the “Medical Device Recall Event Report Form” provided by Elekta, Inc. (USA). This proactive measure ensures patient safety and the reliability of medical devices used in radiation therapy.