Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0704-06

MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system

GE Healthcare / initiated 2006-03-28 / Terminated

GE OEC Medical Systems,Inc began a recall of MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system on . The reason FDA records is "Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0704-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system.
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall
Radiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.
FDA root cause
Other
Action
Consignees were notified by letter prior to 04/28/2006.
Quantity in commerce
534 units (Domestic), 125 (Intl)
Distribution
Nationwide.
Product codes and lots
All MiniView 6800 systems.