OtherIXA
KODAK DIRECTVIEW CR CASSETTE
Received Jul 1, 2006 · Event occurred Apr 5, 2006
Report 1317307-2006-00008 · MDR key 736524
Device
Generic name
Cr Rigid Cassette
Manufacturer
Eastman Kodak CompanyModel number
NACatalog number
NI
Lot number
NI
Product problems
- False Reading From Device Non-Compliance
- Image Resolution Poor
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
A CHEST X-RAY SHOWED AN OSTEOBLASTIC MALIGNANT TUMOR ON AN ELDERLY PT. ADDITIONAL RADIOGRAPHS OF THE SHOULDER AND HUMERUS DID NOT SHOW THE TUMOR.
Additional Manufacturer Narrative
THE CASSETTE HAS BEEN REMOVED FROM USE AND WILL BE EVALUATED BY KODAK ONCE RECEIVED.
Remedial action
- Other