LEKSELL GAMMAPLAN
Received Nov 27, 2025 · Event occurred Oct 29, 2025
Report 3015232217-2025-00073 · MDR key 23664380
Device
Generic name
Radionuclide Rt Treatment Planning System
Manufacturer
Elekta Solutions AbLot number
11.4.2
Product problems
- No Apparent Adverse Event
- Insufficient Device Problem Information
- No Apparent Adverse Event
- 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 AN ISSUE WITH THE CBCT SYSTEM DURING CO-REGISTRATION WHERE SOMETIMES THE IMAGES DO NOT APPEAR AFTER ACQUISITION, OR ARE GETTING ASSIGNED TO THE WRONG PATIENT.
Additional Manufacturer Narrative
H11 UPDATED: THE CUSTOMER REPORTED AN ISSUE WITH THE CBCT SYSTEM DURING CO-REGISTRATION WHERE SOMETIMES THE IMAGES DO NOT APPEAR AFTER ACQUISITION, OR ARE GETTING ASSIGNED TO THE WRONG PATIENT. AN INVESTIGATION WAS ATTEMPTED BY CONDUCTING AN EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE ISSUE COULD NOT BE REPRODUCED AND IT HAS NOT RECURRED AT THE CUSTOMER SITE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER WERE UNSUCCESSFUL. THE GAMMA KNIFE LOG FILE ANALYSIS DOES NOT SHOW ANY IRREGULARITIES CONCERNING THE CBCT IMAGE CREATION. THE LOGFILE CLEARLY INDICATES THAT THE CBCT IMAGES HAVE BEEN RECONSTRUCTED AND SHOWN. HOWEVER, OTHER HARDWARE RELATED PROBLEMS MAY PLAY A ROLE HERE WHICH WOULD NOT BE DETECTED BY LOG FILE ANALYSIS. HARDWARE RELATED PROBLEMS WOULD BE EXPECTED TO HAVE MORE SIGNIFICANT IMPACT THAN INDICATED BY THE CUSTOMER. REGARDING THE ISSUE WITH THE CBCT IMAGES BEING CONNECTED TO THE INCORRECT PATIENT, THIS HAS NOT BEEN POSSIBLE TO CONFIRM IN THE LOGFILES. NO INDICATIONS OF ANYTHING IRREGULAR HAVE BEEN FOUND. THE LOG FILE ANALYSIS INDICATE THAT THE SYSTEM IS WORKING AS INTENDED. IT HAS NOT BEEN POSSIBLE TO ESTABLISH THE ROOT CAUSE. THE RISK OF CBCT IMAGES BEING CONNECTED TO THE WRONG PATIENT IS A WELL-KNOWN RISK WITH MULTIPLE MITIGATIONS IN PLACE. THERE ARE NO INDICATIONS FROM THE LOG FILES THAT THE MITIGATIONS HAVE FAILED OR EVEN BEEN ACTIVATED. THE EXISTING RISKS ARE DEEMED ADEQUATELY MITIGATED. SINCE THE CBCT FUNCTIONALITY WAS RELEASED TO CUSTOMERS IN 2015 NO CASES OF CBCT IMAGES BEING CONNECTED TO THE WRONG PATIENT EXAMINATION IN LGP HAVE BEEN REPORTED. BASED ON AVAILABLE INFORMATION, THERE WAS NO MISTREATMENT.