MalfunctionKGI
HORIZON
Received Jan 10, 2018 · Event occurred Sep 15, 2017
Report 1220984-2018-00052 · MDR key 7180393
Device
Generic name
Densitometer, Bone
Manufacturer
Hologic, Inc.Model number
HORIZON-CICatalog 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 THEY WERE GETTING ERRORS DURING A SCAN, CAUSING THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT RECALIBRATION OF THE FILTER DRUM WAS NEEDED. ONCE THIS WAS DONE, THE SYSTEM IS WORKING AS INTENDED.