Recall Z-2346-2008 ยท LLZ System, Image Processing, Radiological
Philips Healthcare Informatics, Inc.
Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital imaging, measurement, communication and storage.
| Date | Sep 18, 2008 (initiated Jul 3, 2008) |
| Status | Terminated |
| Reason | Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances. |
| Root cause | Software design |
| Action | A "product notification" was issued to the firm's consignees on July 3, 2008. The firm asks consignees to disable MPR until a new software patch can be issued. For assistance contact Philips at 1-877-328-2808. |
| Quantity | 198 systems |
| Distribution | Nationwide in the United States and Canada and internationally to the UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042292 | ISITE PACS Stentor, Inc., Sep 8, 2004 |