OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
This recall has been terminated (originally issued February 15, 2007).
- Company
- Ge Oec Medical Systems, Inc
- Recall Initiated
- January 15, 2007
- Posted
- February 15, 2007
- Terminated
- December 9, 2011
- Recall Number
- Z-0515-2007
- Quantity
- 277 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Uroview 2800 system with 3 Phase Power Distribution Box (Wonder Box) option can present a shock hazard to the user if the access door to the power box is not completely closed when the unit is powered on. .
Distribution
Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.
Lot / Code Info
Model Numbers 882082-01, 882082-02, 886765-01. Units with manufactured dates between 03/2003 and 08/2006.
Root Cause
Other
Action Taken
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.