Recall Z-0616-2007 ยท LLZ System, Image Processing, Radiological
Stentor Inc A Phillips Medical Systems Co.
The iSight PACS (picture archiving and communications system) a software package used with general purpose computer hardware to acquire, store, distribute, process, and display images/associated data throughout a clinical environment.
| Date | Mar 13, 2007 (initiated Feb 14, 2007) |
| Status | Terminated |
| Reason | A defect may cause patient image orientation markers to be incorrectly labeled on Multi-Planar Reformation (MPR) images. Left and Right Anatomical orientation markers may be reversed. |
| Root cause | Other |
| Action | The firm has issued a notification letter to its consignees on 02/14/2007. This notification letter contains preventive measures. |
| Quantity | 54 units |
| Distribution | Worldwide Distribution ---- USA and countries of Australia, Netherlands, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042292 | ISITE PACS Stentor, Inc., Sep 8, 2004 |