HORIZON

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT HAD A HORIZON DXA SCAN OF THE HIP AND SPINE AXIAL ON (B)(6) 2025. THE USER SITE REPORTS THAT ON (B)(6) 2025, THE PATIENT CONTACTED THE USER SITE TO REPORT THAT SHE WAS BURNED BY THE DEVICE. THE USER SITE REPORTS THAT ACCORDING TO THE PATIENT, ON (B)(6) 2025, THE PATIENT STARTED TO NOTICE BLISTERING ON THE FRONT AND BACK OF THE LEGS. THE PATIENT FURTHER REPORTED TO THE USER SITE THAT ON THE EVENING OF (B)(6) 2025, THE PATIENT'S LEGS "LOCKED AND WENT NUMB." IT IS REPORTED THAT THE PATIENT DID NOT SEEK MEDICAL ATTENTION AND SELF-MEDICATED BY PLACING HEATING PADS ON THE LEGS AND TAKING NORCO AND GABAPENTIN, WHICH THE PATIENT ALREADY HAD PRESCRIBED OUTSIDE OF THIS REPORTED EVENT. THE USER SITE REPORTS THAT DURING THE DXA SCAN ON (B)(6) 2025, THE TECHNOLOGIST NOTICED MULTIPLE ARTIFACTS IN THE HIP AND SPINE IMAGES. THE USER SITE REPORTS THAT THE PATIENT CONFIRMED THAT THEY WERE "BUCKSHOT PELLETS." THE USER SITE REPORTS THAT THE PATIENT HAS NOT CONTACTED THEM AGAIN SINCE THE INITIAL CONTACT ON (B)(6) 2025. ADDITIONALLY, THE USER SITE REPORTS THAT THEY HAVE NOT OBSERVED ANY ABNORMALITIES WITH THEIR HORIZON DXA DEVICE. A HOLOGIC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EXAMINE THE DEVICE AND FOUND THE DEVICE TO BE FUNCTIONING IN ACCORDANCE WITH MANUFACTURER SPECIFICATIONS. THE FSE REPORTS THAT THE STAFF AT THE USER SITE INDICATES THAT MULTIPLE PATIENTS HAVE BEEN SCANNED ON THE SYSTEM SINCE THE REPORTED INCIDENT WITHOUT ANY FURTHER COMPLAINTS. NO FURTHER INFORMATION IS AVAILABLE.