MONACO
Received Jun 13, 2025 · Event occurred May 15, 2025
Report 3015232217-2025-00034 · MDR key 22200947
Device
Generic name
System, Planning, Radiation Therapy Treatment
Manufacturer
Elekta Solutions AbLot number
6.1.2.0
Product problems
- Application Program Problem: Dose Calculation Error
- Insufficient Device Problem Information
- Application Program Problem: Dose Calculation Error
- Insufficient Device Problem Information
Patient
NA · Unknown
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
- Insufficient Information
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER'S INVESTIGATION IS ON-GOING AND FURTHER INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS COMPLETED.
Description of Event or Problem
THE CUSTOMER REPORTED A DOSE DISCREPANCY BETWEEN INITIAL AND SECONDARY CALCULATION.
Additional Manufacturer Narrative
THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED A DOSE DISCREPANCY BETWEEN THE INITIAL AND SECONDARY CALCULATIONS. ELEKTA PERFORMED TESTING TO REPRODUCE THE ISSUE; HOWEVER, THE SCENARIO DESCRIBED BY THE CUSTOMER COULD NOT BE REPLICATED. NO DEVICE PROBLEM WAS FOUND. ADDITIONALLY, THE CUSTOMER HAS BEEN UNABLE TO REPRODUCE THE ERROR. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF PATIENT MISTREATMENT.