ClearanceBrief
Recall Z-0704-06 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified

GE OEC Medical Systems,Inc

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

DateSep 30, 2006 (initiated Mar 28, 2006)
StatusTerminated
ReasonRadiation exposure rate could exceed specifications during fluoroscopic x-ray procedure.
Root causeOther
ActionConsignees were notified by letter prior to 04/28/2006.
Quantity534 units (Domestic), 125 (Intl)
DistributionNationwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K992506MINI 6800 DIGITAL MOBILE C-ARM
Ge Dec Medical Systems, Aug 19, 1999