Uroview 2000 X-ray System
FDA device recall Z-0945-03 · posted 2003-06-21 · Terminated
Recall details
- Recalling firm
- GE OEC Medical Systems,Inc
- Reason for recall
- Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.
- Action taken
- A Product Safety Alert letter was sent to all consignees on 5/12/2003 recommending that all hand controls be removed from the units.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 211 units
- Distribution
- Nationwide. Foreign distribution to Argentina, Australia, Austria, Canada, Germany, Italy, Japan, Mexico, Russia and Switzerland.
- Date initiated
- 2003-05-12
- Date posted
- 2003-06-21
- Date terminated
- 2011-07-07
- 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 2000, MODIFICATION (K914446) | Oec-Diasonics, Inc. | 1992-01-10 |
| UROVIEW II (K893475) | Oec-Diasonics, Inc. | 1989-08-10 |