inforMED
MalfunctionKGI

HORIZON

Received Jan 19, 2018 · Event occurred Dec 21, 2017

Report 1220984-2018-00082 · MDR key 7207649

Device

Generic name

Densitometer, Bone

Manufacturer

Hologic, Inc

Model number

HORIZON-CI

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 AN ERROR WAS RECEIVED WHILE TRYING TO REPOSITION DURING A PATIENT EXAM, WHICH REQUIRED THE PATIENT TO BE RE-EXPOSED. IT WAS DETERMINED THAT THE C-ARM INTERFACE BOARD NEEDED TO BE REPLACED. ONCE THE BOARD WAS REPLACED THE SYSTEM IS WORKING AS INTENDED.