MalfunctionIYY
PET ADVANCE GANTRY
Received Jun 29, 2000 · Event occurred May 11, 2000
Report 2126677-2000-00007 · MDR key 284748
Device
Generic name
Nuclear Medicine
Manufacturer
Ge Medical SystemsModel number
46-311001Catalog number
NA
Lot number
NA
Product problems
- Component Missing
Patient
NA
Narrative
Description of Event or Problem
MANUFACTURING DISCOVERED A MISSING LOCK NUT FROM THE TILT MECHANISM OF THE PET ADVANCE GANTRY ON SOME SYSTEMS. THIS COULD POTENTIALLY LEAD TO FAILURE OF THE TILT MECHANISM, WHICH IN SOME GANTRY ORIENTATIONS MIGHT RESULT IN UNWANTED TILT OF THE GANTRY TOWARD THE PT, POSSIBLY RESULTING IN INJURY. THERE HAVE BEEN NO REPORTS OF INJURY ASSOCIATED WITH THIS INTERNAL FINDING.