GALILEOS

Description of Event or Problem

A PATIENT ASKED ABOUT DOSE CONVERSION FACTORS AND MENTIONED A CLOUDY EYE AND REDUCED VISION AFTER A 3D DVT X-RAY SCAN WAS PERFORMED BY A DENTAL PRACTICE AND AFTER IMAGE WAS TAKEN.

Additional Manufacturer Narrative

HERE ARE DIFFERENT DEFINITIONS FOR DOSE MEASURING'S: FOR A STANDARD EXPOSURE, THE EFFECTIVE DOSE IS BE-TWEEN 38 #SV AND 154 #SV. THE RADIATION EXPOSURE IS CALCULATED AS THE DOSE AREA PRODUCT (DFP) OF THE-ABSORBED DOSE (GY X CM²) PER MAS OF EACH SELECTABLE LEVEL AND APERTURE IS GIVEN BETWEEN 171MGYCM2 AND 1139 MGYCM2. THIS IS ABOUT A FACTOR OF 1000 LESS THAN THE VALUE STATED BY MS. PFIRRMANN. GALILEOS WORKS WITH FIXED KV/MA VALUE PAIRS. THE PATIENT'S CONCLUSION IN HER LETTER THAT 1120MGY WERE APPLIED IS NOT ADMISSIBLE. WE HAVE TWO DIFFERENT PHYSICAL QUANTITIES HERE, THE DOSE AREA PRODUCT AND THE EFFECTIVE DOSE. THEREFORE, HER FURTHER CON-CLUSION THAT 135 MSV WERE APPLIED IS NOT ADMISSIBLE. WE WOULD REFER HERE TO THE STUDY BY LUDLOW AT (HTTPS://PMC.NCBI.NLM.NIH.GOV/ARTICLES/PMC4277438/). PATIENT WAS INFORMED ABOUT: THE INTERPRETATION OF DIFFERENT DOSE MEASURES, TO CONSULT FURTHER MEDICAL ACTIONS IN CASE OF NEED AND TO INFORM US ABOUT THE CONTACT INFORMATION OF THE INITIAL DENTAL PRACTICE WHO APPLIED THE X-RAY DIAGNOSIS. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.