Objective To construct a failure mode and effects analysis (FMEA) model for risk management of cone-beam CT equipment and improve the level of equipment management.

Methods The lean management tool FMEA was used for full-process management evaluation. A total of 15 cone-beam CT devices were selected, and four types of failure modes, including technical performance, environmental interference, system software, and operation norms, were identified. A total of 58 failure modes were confirmed, among which 10 were high-risk items. Effective interventions were carried out on the high-risk items, and a questionnaire survey was conducted to evaluate the results, dividing the subjects into an experimental group and a control group.

Results The χ² test and t-test were performed using SPSS 29.0. Compared before and after the intervention, the mean risk priority number (RPN) of the operation norms, environmental interference, system software, and technical performance categories decreased significantly. The differences in RPN values and work quality evaluations before and after the intervention were statistically significant.

Conclusion The FMEA model can be used for refined and scientific risk management of cone-beam CT equipment, effectively enhancing the operational capacity of medical equipment and improving the quality of clinical services.