FDA Recall
Terminated
Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive
Recall: Z-0009-04
·
Initiated August 8, 2003
Recall
- Recall Number
- Z-0009-04
- Event Number
- 27023
- Firm
- Siemens Medical Solutions USA, Inc
- FEI Number
- 2240869
- Product Code
- JAA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 8, 2003
- Posted
- October 15, 2003
- Terminated
- January 16, 2004
- Address
- 51 Valley Stream Parkway, Malvern, PA, 19355
Description
Urology X-Ray System, Uroskop D1/D2/D3 - Hardware for Motor Drive
Reason
possible movement of table tilt and table longitudinal
Action
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.
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.
Quantity
34 units