MalfunctionIXY
PEGASYS
Received Jul 11, 2000 · Event occurred Mar 29, 2000
Report 2916556-2000-00296 · MDR key 286126
Device
Generic name
Nuclear Medicine Equipment
Manufacturer
Adac LaboratoriesModel number
2144-3000ACatalog number
*
Lot number
NA
Product problems
- Image Orientation Incorrect
- Malfunction
Patient
UNKNOWN
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
WHEN ACTIVATED, AUTOQUANT IS NOT NORMALIZING ACCORDING TO THE GIVEN PARAMETERS. IT INCLUDES AREAS NOT INSIDE THE REGIONS AND PERFORMS SOME TYPE OF AVERAGING. THIS MAY CAUSE IMAGES TO BE MIS-REPRESENTED. NO INJURIES REPORTED.