MalfunctionLMD

IMAGELINK TM

Received Feb 28, 2005

Report 3004120479-2005-00001 · MDR key 580506

Device

Generic name

Medical Image Communications Device

Manufacturer

Computer Programs And Systems, Inc.

Model number

Catalog number

Lot number

Product problems

Device Issue

Patient

Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

THE REPORTED PROBLEM THAT IS UNDER INVESTIGATION IS THE REGION OF INTEREST (ROI) TOOL FOR MEASURING DENSITY, IN HOUNSFIELD UNITS (HU), ON COMPUTED TOMOGRAPHY(CT) SCANS. THE TOOL IS NOT CALCULATING PROPERTY. THE EXAMPLE PROVIDED WAS DENSITY MEASURED IN THE CETER OF THE THALAMUS ON A NORMAL BRAIN WHICH SHOULD MEASURE IN THE RANGE OF 40-50 HU ONLY MEASURED 14 HU.

Remedial action

Repair