MalfunctionRCC
FLOUROSCOPIC SYSTEM
Received Jul 7, 2025
Report MW5172283 · MDR key 22412588
Device
Generic name
C-arm Fluoroscopic X-ray System
Manufacturer
UnknownProduct problems
- Image Orientation Incorrect
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
(B)(6) (CC) CALLED TO REPORT THAT THE C-ARM IMAGE WAS ROTATED 45 DEGREES WHEN TRANSFERRED OVER TO THE STEALTH. TROUBLESHOOTING: TS RECOMMENDED TAKING ANOTHER C-ARM IMAGE. THEY TOOK ANOTHER IMAGE, AND IT APPEARED STRAIGHT ON THE STEALTH. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).