Recall Z-2341-2012 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified
Siemens Medical Solutions USA, Inc
Siemens Uroskop Access. Fluoroscopic, image intensified x-ray system
| Date | Sep 10, 2012 (initiated Apr 30, 2012) |
| Status | Terminated |
| Reason | Siemens has discovered a possible hazard to patients or hospital personnel when tilting the Uroskop Access system starting with serial number 6076. When tilting the table on the Uroskop Access table, the motor may become disconnected and the entire table assembly may fall on the floor. |
| Root cause | Nonconforming Material/Component |
| Action | Siemens sent a Update instructions letter dated April 2012, to all affected customers. The safety instruction letter identified the product the problem and the action needed to be taken by the customer. The update has been completed successfully. The customer has been informed of the benefits of improvements resulting from this update. Further questions please call (610) 219-4834. |
| Quantity | 5 |
| Distribution | Nationwide distribution: USA including states of: IN, MI, MS, TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010942 | U04 Siemens Medical Solutions USA, Inc., Apr 12, 2001 |