MalfunctionKGI
HORIZON
Received Dec 28, 2017 · Event occurred Nov 29, 2017
Report 1220984-2017-00295 · MDR key 7152115
Device
Generic name
Densitometer, Bone
Manufacturer
Hologic, Inc.Model number
HORIZON-WCatalog number
N/A
Lot number
N/A
Product problems
- Device Displays Incorrect Message
- Device Displays Incorrect Message
Patient
Not reported
- Not Applicable
- Not Applicable
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER THEY WERE GETTING ERRORS DURING A SCAN, CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT RECALIBRATION OF THE FILTER DRUM AND APERTURE WERE NEEDED AS WELL AS ADJUSTING THE GAIN. ONCE THIS WAS DONE, THE SYSTEM IS WORKING AS INTENDED.