Uroskop D1/D2/D3 - Table, Radiographic, Stationary Top.
FDA device recall Z-0493-03 · posted 2003-01-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Systems Inc
- Reason for recall
- There is unintended system movement or unwanted automatic movement of the tabletop.
- Action taken
- Siemens personal will install Host Software VA00F and Generator Host Software VE00D on affected Uroskop units. Update instructions were sent to users November 27,2002 and December 7, 2002.
- Root cause
- Other
- Status
- Terminated
- Product code
- IXR
- Quantity affected
- 13
- Distribution
- Product was distributed to 6 hospitals nationwide and 5 government hospitals. Internationally, the tables were distributed to Germany, Netherlands, Italy , Luxembourg, Sweden, Austria, Switzerland, Sl
- Date initiated
- 2002-11-27
- Date posted
- 2003-01-30
- Date terminated
- 2005-01-10
- Location
- Iselin, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UROSKOP D1, UROSKOP D2, AND UROSKOP D3 (K923049) | Siemens Medical Solutions USA, Inc. | 1992-09-15 |