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.
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