China NMPA Product Recall - Radiotherapy patient positioning system

On September 19, 2019, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Medical Intelligence Medizintechnik GmbH. The recall, reported by Elekta (Shanghai) Medical Device Co., Ltd., pertains to the company's radiotherapy patient positioning system, registered under certificate number 20173311406. The primary issue prompting this action is a potential system malfunction stemming from inconsistencies in decimal separator settings across different countries. This discrepancy could impact the system's operational accuracy, posing a risk to patient safety. As a required action under NMPA's regulatory framework, Medical Intelligence Medizintechnik GmbH is voluntarily recalling affected models, specifications, and batches of the radiotherapy patient positioning system. The Class II designation signifies that the product might cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. Further details regarding the specific products involved are available in the accompanying recall event report. This recall highlights the importance of stringent software localization and robust quality control in medical device manufacturing to ensure consistent performance and patient well-being across diverse international markets.