Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive
FDA device recall Z-0009-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- possible movement of table tilt and table longitudinal
- Action taken
- The recalling firm issued Update Instructions SP016/03/S, SP017/03S and SP018/03/S that instruct the Service Engineers to visit each affected system to install the required parts.
- Root cause
- Other
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 34 units
- Distribution
- Nationwide. The product was shipped to medical facilities in CA, FL, GA, IL, MD, NC, NJ, NY, OK, PA, SC, TN, TX, VA, WI, and WV.
- Date initiated
- 2003-08-08
- Date posted
- 2003-10-15
- Date terminated
- 2004-01-16
- Location
- Malvern, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UROSKOP D1, UROSKOP D2, AND UROSKOP D3 (K923049) | Siemens Medical Solutions USA, Inc. | 1992-09-15 |