LEKSELL GAMMAPLAN

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 MISMATCH OF MR VS CBCT #1.

Additional Manufacturer Narrative

H11: UPDATED: THE INVESTIGATION WAS COMPLETED BY CONDUCTING A THOROUGH EVALUATION OF THE PRODUCT AND THE REPORTED INFORMATION. THE CUSTOMER REPORTED A MISMATCH OF MR VS CBCT #1. AN AVM TREATMENT WAS PLANNED USING A COMBINATION OF FRAME-BASED AND FRAMELESS IMAGES AND PLANNED FOR DELIVERY USING FOUR TREATMENTS. AFTER DELIVERY OF THE THIRD TREATMENT, IT WAS DISCOVERED THAT THE PLAN DID NOT CORRECTLY ALIGN ON THE STEREOTACTIC CBCT IMAGES. IT WAS CONCLUDED THAT THE PLAN RESULTED IN MISTREATMENT OF THE PATIENT WITH DOSE BEING DELIVERED IN THE WRONG POSITION. THE ROOT CAUSE IS THAT THE PLAN WAS NOT PROPERLY UPDATED AFTER CHANGING FIXATION. THE CLEAR DISCREPANCIES THAT THIS CAUSED WERE NOT PROPERLY REVIEWED OR ACTED UPON BEFORE THE APPROVAL OF THE PLAN. THE SYSTEM WORKED AS DESIGNED AND INTENDED. ELEKTA HAVE NOT BEEN PROVIDED WITH INFORMATION REGARDING THE PATIENT'S CONDITION. AN IMPORTANT FIELD SAFETY NOTICE (100-01-102-019) HAS BEEN SENT TO ALL AFFECTED CUSTOMERS FROM 17 DECEMBER 2025 ELEKTA REFERENCE #: (B)(4). TO REDUCE THE LIKELIHOOD FOR ERRONEOUS USE OF OBSOLETE STEREOTACTIC REFERENCE FOR TREATMENTS WITH A FRAME, LEKSELL GAMMAPLAN® 11.5 WILL NO LONGER PERMIT THE USE OF STEREOTACTIC CBCT REFERENCE IN COMBINATION WITH OTHER STEREOTACTIC REFERENCES.