China NMPA Product Recall - Radiotherapy planning software

On August 17, 2021, Elekta (Shanghai) Medical Device Co., Ltd. initiated a voluntary Class III recall of its radiotherapy planning software, identified by Registration Certificate No. 国械注进 20153210147. This action was taken in response to a specific malfunction observed when the software was employed with MRI-guided radiotherapy systems. The issue occurred due to unconventional operating methods used by clinicians, which could lead to treatment beds not being correctly assigned within the system plan. This problem is strictly confined to particular non-routine operating procedures and does not impact radiotherapy planning software utilized with other Elekta accelerator models. The National Medical Products Administration (NMPA) of China publicly announced this recall, indicating that comprehensive details concerning affected product models, specifications, and batches are contained within the "Medical Device Recall Event Report Form." This proactive recall underscores the company's commitment to patient safety and compliance with the regulatory standards established by Chinese medical device authorities, ensuring prompt resolution of potential risks and maintenance of device reliability in clinical practice.