inforMED
MalfunctionKGI

QDR

Received Dec 22, 2017 · Event occurred Nov 29, 2017

Report 1220984-2017-00272 · MDR key 7144102

Device

Generic name

Densitometer, Bone

Manufacturer

Hologic, Inc.

Model number

RM-QDR-4500C

Catalog number

N/A

Lot number

N/A

Product problems

  • Poor Quality Image
  • Poor Quality Image

Patient

Not reported

  • Not Applicable
  • Not Applicable

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THEY WERE GETTING HORIZONTAL LINES IN THE IMAGES CAUSING THE PATIENT TO BE RE-EXPOSED. THE FE PERFORMED THE APERTURE CALIBRATION, ONCE THIS WAS DONE, THE UNIT IS WORKING AS INTENDED.