Recall Z-0841-03 ยท LLZ System, Image Processing, Radiological
Siemens Medical Solutions USA, Inc
Leonardo MM-WS systems. System, Image Processing.
| 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 | 2 |
| 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
| K010938 | SYNGO MULTIMODALITY WORKSTATION Siemens Medical Solutions USA, Inc., Jun 26, 2001 |