KODAK DIRECTVIEW CR CASSETTE
Received Jul 1, 2006 · Event occurred Apr 24, 2006
Report 1317307-2006-00010 · MDR key 736514
Device
Generic name
Cr Rigid Cassette
Manufacturer
Eastman Kodak CompanyModel number
NACatalog number
132-4326
Lot number
1799
Product problems
- Signal Artifact/Noise
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
AN ARTIFACT ON A RADIOGRAPH OF THE RIGHT KNEE RESEMBLED A BONE TUMOR DISTAL FEMUR. WHEN READING THE RADIOGRAPH, THE RADIOLOGIST THOUGHT WHAT HE OBSERVED WAS AN ARTIFACT BUT RAN AN ADDITIONAL RADIOGRAPH TO CLARIFY AND CONFIRM.
Additional Manufacturer Narrative
KODAK RECEIVED THE SCREEN AND CASSETTE FOR EVALUATION. OUR EVALUATION INCLUDED CREATING AND PRINTING FLAT FIELD IMAGES AND A PHYSICAL EXAMINATION OF THE SCREEN. THE FLAT FIELD IMAGES WERE PRINTED AT AN EXTREME CONTRAST IN ORDER TO EHANCE ANY IMAGE ARTIFACTS. THE FLAT FIELD IMAGES SHOWED ARTIFACTS THAT WAS CLASSIFIED AS MOTTLE. THE PHYSICAL EXAMINATION DID NOT SHOW ANY PHYSICAL DAMAGE TO THE SCREEN. ARTIFACT INVESTIGATION CONDUCTED BY KODAK HAVE SHOWN THAT MOTTLE ARTIFACTS IS CAUSED WHEN A SCREEN IS RE-INSERTED INTO A CASSETTE NOT FULLY DRY. THE CLEANING SOLUTION IS THEN ABSORBED BY THE PROTECTIVE FOAM AND, IN CONTACT WITH THE SCREEN SURFACE, WILL CAUSE AN ARTIFACT. THE AFFECTED CR SCREEN WAS REMOVED AND REPLACED WITH A NEW CR SCREEN.
Remedial action
- Replace