China NMPA Product Recall - Radiation Treatment Planning System

Elekta, Inc. (USA) has initiated a voluntary Class III recall of its Radiation Treatment Planning System software (Registration Certificate No.: 20153210147), as publicly announced by the National Medical Products Administration (NMPA) on August 3, 2021. This action, managed by Elekta (Shanghai) Medical Device Co., Ltd., addresses identified calculation problems within early versions of specific models and batches of the software. These issues are reported to occur in certain usage scenarios, which could potentially impact the accuracy and safety of radiation treatment planning. The main issue revolves around software performance discrepancies that could lead to erroneous calculations, a critical component in patient therapy. While the document does not mention specific inspection dates, the voluntary nature of the recall indicates the company's proactive response to internal or reported findings. The regulatory framework for this recall is established under the NMPA, which is responsible for overseeing medical devices in China, ensuring manufacturers adhere to stringent quality and safety standards. Required actions involve the recall of the affected software products to prevent further use of the potentially faulty versions. The "Medical Device Recall Event Report Form" provides detailed information on the specific models and batches requiring this corrective action. This measure underscores the company's commitment to patient safety and compliance with regulatory expectations, aiming to resolve identified deficiencies and restore confidence in their medical device software.