This study applies Failure Modes, Effects, and Criticality Analysis (FMECA) to evaluate and enhance the reliability of the Neusoft NeuViz Scanner, a critical medical imaging device. A multidisciplinary team of radiology experts and engineers conducted a two-year investigation into the complex dynamics of gantry and console components. Key critical components identified include the F102 fuse holder, left control panel card, Ucom card, DMS system, and RDC card. Criticality indices were calculated based on frequency, severity, and detectability. The study proposes a three-tiered approach: preventive, corrective, and improvement actions. Preventive measures include thorough inspections, cable evaluations, lubrication, planning for the gantry, and cleaning procedures for the console. Corrective actions involve card and cable replacements. Innovative improvements include incorporating Uninterruptible Power Supplies, adding a second console, and implementing a voltage regulator. The study aligns with ISO 14971 and the European Union Medical Devices Regulation (MDR) 2017/745, ensuring compliance with stringent medical device standards. This research provides valuable insights into systematically evaluating and mitigating risks, offering practical strategies for improving reliability, patient safety, and adherence to medical device regulations. It is the first study to apply FMECA for the analysis and management of failures in CT scanners. Computed tomography (CT) has evolved significantly since its inception in the 1970s, with advancements leading to the development of spiral CT and other generations. Risk analysis is crucial during the design phase of electromedical equipment to ensure safety and reliability. FMECA is a key technique for identifying and assessing failure consequences in complex systems. The study highlights the importance of adhering to relevant standards, particularly the MDR, for Class IIb medical devices like CT scanners. The research underscores the need for rigorous risk management to ensure the safety and effectiveness of medical imaging devices.This study applies Failure Modes, Effects, and Criticality Analysis (FMECA) to evaluate and enhance the reliability of the Neusoft NeuViz Scanner, a critical medical imaging device. A multidisciplinary team of radiology experts and engineers conducted a two-year investigation into the complex dynamics of gantry and console components. Key critical components identified include the F102 fuse holder, left control panel card, Ucom card, DMS system, and RDC card. Criticality indices were calculated based on frequency, severity, and detectability. The study proposes a three-tiered approach: preventive, corrective, and improvement actions. Preventive measures include thorough inspections, cable evaluations, lubrication, planning for the gantry, and cleaning procedures for the console. Corrective actions involve card and cable replacements. Innovative improvements include incorporating Uninterruptible Power Supplies, adding a second console, and implementing a voltage regulator. The study aligns with ISO 14971 and the European Union Medical Devices Regulation (MDR) 2017/745, ensuring compliance with stringent medical device standards. This research provides valuable insights into systematically evaluating and mitigating risks, offering practical strategies for improving reliability, patient safety, and adherence to medical device regulations. It is the first study to apply FMECA for the analysis and management of failures in CT scanners. Computed tomography (CT) has evolved significantly since its inception in the 1970s, with advancements leading to the development of spiral CT and other generations. Risk analysis is crucial during the design phase of electromedical equipment to ensure safety and reliability. FMECA is a key technique for identifying and assessing failure consequences in complex systems. The study highlights the importance of adhering to relevant standards, particularly the MDR, for Class IIb medical devices like CT scanners. The research underscores the need for rigorous risk management to ensure the safety and effectiveness of medical imaging devices.