Recall Z-2338-2015 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA Inc.
Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
| Date | Aug 5, 2015 (initiated Jul 14, 2015) |
| Status | Terminated |
| Reason | Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring. |
| Root cause | Packaging change control |
| Action | The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015. |
| Quantity | 1 unit |
| Distribution | Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123737 | BIOGRAPH MCT FAMILY Siemens Medical Solutions USA, Inc., Jan 29, 2013 |