RESIUS 190 XPRES
Received Oct 13, 2009 · Event occurred Oct 12, 2009
Report 1509706 · MDR key 1509706
Device
Generic name
Imaging Plate, Computed Radiography
Manufacturer
Konica-minolta Medical Imaging Usa, Inc.Model number
RESIUS 190 XPRESSCatalog number
*
Lot number
*
Product problems
- Signal Artifact/Noise
- Disassembly
Patient
*
- No Information
Narrative
Description of Event or Problem
OF THE 108 PLATES PUT INTO USE, 60 PLATES HAVE DEVELOPED FLAWS OR ARTIFACTS. THESE ARTIFACTS IF NOT DETECTED COULD RESULT IN ADDITIONAL DIAGNOSTIC TESTING AND POTENTIAL HARM.BEGINNING IN SEPT 2007, THIS FACILITY RETURNED 28 OF THE 43 14" X 17" PLATES UNDER WARRANTY TO KONICA AND RECEIVED REPLACEMENT. SUBSEQUENTLY, AN ADDITIONAL 41 PLATES WERE FOUND TO BE FLAWED. KONICA TOLD THIS HOSPITAL THAT NO OTHER FACILITIES HAVE REPORTED THIS TYPE OF ISSUE.THE ARTIFACT ON THE IMAGING PLATES APPEARS AS A SMALL AREA(S) OF HIGHER ATTENTUATION THAT CAN BE MISTAKEN FOR CALCIFICATION.WE BELIEVE THAT THE CAUSE MAY BE CHIPS OF GLUE WHICH FALL BETWEEN THE COVER AND THE IMAGED STORAGE PLATE. THE GLUE IS USED TO HOLD THE METAL FRAME SURROUNDING THE CASSETTE.
Description of Event or Problem
OF THE 108 PLATES PUT INTO USE, 60 PLATES HAVE DEVELOPED FLAWS OR ARTIFACTS. THESE ARTIFACTS IF NOT DETECTED COULD RESULT IN ADDITIONAL DIAGNOSTIC TESTING AND POTENTIAL HARM.BEGINNING IN SEPT 2007, THIS FACILITY RETURNED 28 OF THE 43 14" X 17" PLATES UNDER WARRANTY TO KONICA AND RECEIVED REPLACEMENT. SUBSEQUENTLY, AN ADDITIONAL 41 PLATES WERE FOUND TO BE FLAWED. KONICA TOLD THIS HOSPITAL THAT NO OTHER FACILITIES HAVE REPORTED THIS TYPE OF ISSUE.THE ARTIFACT ON THE IMAGING PLATES APPEARS AS A SMALL AREA(S) OF HIGHER ATTENTUATION THAT CAN BE MISTAKEN FOR CALCIFICATION.WE BELIEVE THAT THE CAUSE MAY BE CHIPS OF GLUE WHICH FALL BETWEEN THE COVER AND THE IMAGED STORAGE PLATE. THE GLUE IS USED TO HOLD THE METAL FRAME SURROUNDING THE CASSETTE.