InjuryJAA
OEC ELITE
Received Jul 10, 2026 · Event occurred Jun 11, 2026
Report MW5190566 · MDR key 25778264
Device
Generic name
System, X-ray, Fluoroscopic, Image-intensified
Manufacturer
Ge Oec Medical Systems IncPatient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
(B)(6) (PRODUCT MANAGER) EMAILED TO REPORT THAT FLUORO SHOTS WERE WASHED OUT (COMPLETELY WHITE) AND LEVEL/WIDTH NEEDED TO BE ADJUSTED TO SEE IMAGES IN VERIFY REGISTRATION TASK. C-ARM MODEL WAS A GE OEC ELITE FLAT PANEL. PATIENT PRESENT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).