ClearanceBrief
Recall Z-0945-03 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified

GE OEC Medical Systems,Inc

Uroview 2000 X-ray System

DateJun 21, 2003 (initiated May 12, 2003)
StatusTerminated
ReasonUncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
Root causeOther
ActionA Product Safety Alert letter was sent to all consignees on 5/12/2003 recommending that all hand controls be removed from the units.
Quantity211 units
DistributionNationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K893475UROVIEW II
Oec-Diasonics, Inc., Aug 10, 1989
K914446UROVIEW 2000, MODIFICATION
Oec-Diasonics, Inc., Jan 10, 1992