Recall Z-0514-2007 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
GE OEC Medical Systems, Inc
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.
| Date | Feb 15, 2007 (initiated Jan 15, 2007) |
| Status | Terminated |
| Reason | Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall. |
| 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 | 425 units |
| Distribution | Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993687 | UROVIEW 2800 Ge Dec Medical Systems, Dec 21, 1999 |