MalfunctionKGI
HORIZON
Received Nov 22, 2017 · Event occurred Sep 11, 2017
Report 1220984-2017-00207 · MDR key 7052987
Device
Generic name
Densitometer, Bone
Manufacturer
Hologic, Inc.Model number
HORIZON-WCatalog number
N/A
Lot number
N/A
Product problems
- Poor Quality Image
- Device Displays Incorrect Message
- Poor Quality Image
- 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 THE DETECTOR NEEDED TO BE REPLACED. ONCE THIS WAS DONE THE SYSTEM IS WORKING AS INTENDED.