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OtherIXA

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

Model number

NA

Catalog 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