Recall Z-0399-06 ยท LLZ System, Image Processing, Radiological
Stentor Inc
''iSite'' PowerScribe/iSite Integration, Picture Archiving and Communication System, software version 3.3
| Date | Jan 18, 2006 (initiated Dec 20, 2005) |
| Status | Terminated |
| Reason | When using a third party dictation accessory with the iSite PACS, a malfunction may occur that would result in the petient/exam selected and shown may be different on the radiologist console and diagnostic display screens |
| Root cause | Other |
| Action | On 12/20/05, the firm initiated the recall and its notification was via letters informing its customers of the corrective action. |
| Quantity | 110 units |
| Distribution | Product was distributed nationwide to 66 direct consignees. There were no shipments to U.S. Government facilities or foreign or Canadian distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042292 | ISITE PACS Stentor, Inc., Sep 8, 2004 |