OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 8820
FDA device recall Z-0515-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems, Inc
- 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. .
- 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
- 277 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
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UROVIEW 2800 (K993687) | Ge Dec Medical Systems | 1999-12-21 |