Recall Z-0842-03 ยท KPS System, Tomography, Computed, Emission
Siemens Medical Solutions USA, Inc
Somatom Sensation 16, Computed Tomography System, Diagnostic Imaging.
| Date | May 16, 2003 (initiated Oct 11, 2002) |
| Status | Terminated |
| Reason | Perfusion CT is displaying a higher gray and color values than normal. A software problem. |
| Root cause | Other |
| Action | Update instructions on the new software were sent to the three customers on 8/2/2002. This update was followed up by a service representative to actually install the software. |
| Quantity | 1 |
| Distribution | The product was distributed to three hospitals: Cleveland Clinic Foundation, Cleveland, OH; Brigham & Womens Hospital, Boston, MA; and Barnes Jewish Hosp. South Campus, Saint Louis, MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013522 | SOMATOM P30 CT SYSTEMS Siemens Medical Systems, Inc., Nov 7, 2001 |