KODAK DIRECTVIEW CR CASSETTE
Received Jul 1, 2006 · Event occurred Jan 18, 2006
Report 1317307-2006-00006 · MDR key 736446
Device
Generic name
Cr Rigid Cassette
Manufacturer
Eastman Kodak CompanyModel number
NACatalog number
890-7321
Lot number
1814
Product problems
- Signal Artifact/Noise
Patient
Not reported
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A RADIOGRAPH TAKEN FOR A TRAUMA CASE SHOWED A FOREIGN BODY. ADDITIONAL RADIOGRAPHS WERE TAKEN TO LOCATE THE FOREIGN BODY AND THESE SHOWED NO FOREIGN BODY.
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 IMAGE SHOWED ARTIFACTS THAT WERE CLASSIFIED AS FINGERPRINT ARTIFACTS. THESE WERE LOCATED AT THE EDGES AND CORNERS OF THE IMAGE. THE PHYSICAL EXAMINATION SHOWED AN AREA WITH A SMALL ABRASION AT THE BOTTOM OF THE SCREEN. IN THE FLAT FIELD IMAGE THIS LOOKED LIKE A FOREIGN BODY. THE FINGERPRINT ARTIFACTS HAVE BEEN SEEN ON OTHER CR IMAGES AND ARE ASSOCIATED WITH HANDLING OF THE SCREENS BY BARE HANDS. MANY LOTIONS AND WATERLESS HAND CLEANERS CONTAIN CHEMICALS THAT CAN DAMAGE PHOSPHOR SCREENS. THE AFFECTED CR SCREEN WAS REMOVED AND REPLACED WITH A NEW CR SCREEN.
Remedial action
- Replace