OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 882082-01, 882082-02, 886765-01, GE
FDA device recall Z-0514-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- Reason for recall
- Uroview 2800 system with dual monitors may pose a safety risk to patients if the monitors become disconnected and fall.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 425 units
- Distribution
- Worldwide, including USA, Canada, China, France, Germany, Hong Kong, Italy, Japan, Singapore, South Africa, Switzerland, and Venezuela.
- Date initiated
- 2007-01-15
- Date posted
- 2007-02-15
- Date terminated
- 2011-12-09
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UROVIEW 2800 (K993687) | Ge Dec Medical Systems | 1999-12-21 |