This study applies Failure Modes, Effects, and Criticality Analysis (FMECA) to enhance the reliability of the Neusoft NeuViz CT scanner, a critical medical imaging device. A specialized working group, comprising radiology experts and engineers, conducted a two-year investigation into the dynamics of gantry and console components. The study identified critical elements such as the F102 fuse holder, left control panel card, Ucom card, DMS system, and RDC card, and calculated criticality indices based on Frequency, Severity, and Detectability. The results guide a three-tiered approach: preventive measures (inspections, cable evaluations, lubrication, and cleaning), corrective actions (card and cable replacements), and innovative improvements (Uninterruptible Power Supplies, a second console, and voltage regulation). The study aligns with ISO 14971 and European Union Medical Devices Regulation standards, providing valuable insights into risk evaluation and mitigation, enhancing reliability, patient safety, and regulatory compliance. This research is the first to use FMECA for CT scanner failures, offering practical strategies for improving device reliability and adherence to medical device regulations.This study applies Failure Modes, Effects, and Criticality Analysis (FMECA) to enhance the reliability of the Neusoft NeuViz CT scanner, a critical medical imaging device. A specialized working group, comprising radiology experts and engineers, conducted a two-year investigation into the dynamics of gantry and console components. The study identified critical elements such as the F102 fuse holder, left control panel card, Ucom card, DMS system, and RDC card, and calculated criticality indices based on Frequency, Severity, and Detectability. The results guide a three-tiered approach: preventive measures (inspections, cable evaluations, lubrication, and cleaning), corrective actions (card and cable replacements), and innovative improvements (Uninterruptible Power Supplies, a second console, and voltage regulation). The study aligns with ISO 14971 and European Union Medical Devices Regulation standards, providing valuable insights into risk evaluation and mitigation, enhancing reliability, patient safety, and regulatory compliance. This research is the first to use FMECA for CT scanner failures, offering practical strategies for improving device reliability and adherence to medical device regulations.