inforMED
MalfunctionKGI

HORIZON

Received Nov 7, 2017 · Event occurred Oct 9, 2017

Report 1220984-2017-00135 · MDR key 7006817

Device

Generic name

Densitometer, Bone

Manufacturer

Hologic, Inc.

Model number

HORIZON-A

Catalog 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 SCAN THE FILE FAILED TO OPEN, CAUSING THE PATIENT TO BE RE-EXPOSED. RESTARTING THE SYSTEM RESOLVE THE ISSUE.