Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0514-2007

OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 882082-01, 882082-02...

GE Healthcare / initiated 2007-01-15 / Terminated

GE OEC Medical Systems, Inc began a recall of OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT on . The reason FDA records is "Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0514-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
GE Healthcare
Product
OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
Product code
JAA System, X-Ray, Fluoroscopic, Image-Intensified
Reason for recall
Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall.
FDA root cause
Other
Action
Consignees were notified by letter on 01/15/2007. Instructions were given to position and not move the dual monitors until inspection and correction by GE personnel. For the affected units with a 3 phase power distribution box, users were cautioned to ensure that the access door to the power box is completely closed when the unit is powered on to prevent a shock hazard.
Quantity in commerce
425 units
Distribution
Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.
Product codes and lots
Model Numbers: 882082-01, 882082-02, 886765-01. Units with manufactured dates between 03/2003 and 08/2006.