Recall Z-1443-2008 ยท LLZ System, Image Processing, Radiological
Philips Healthcare Informatics, Inc.
Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 3.6.28.0 - Radiology Image management system.
| Date | Aug 16, 2008 (initiated Jan 29, 2008) |
| Status | Terminated |
| Reason | When using the Freehand Region of Interest (ROI) tool, errors may occur in area calculation yielding incorrect results. The firm discovered that a descrepancy exists in the measurement provided by the tool. |
| Root cause | Software design |
| Action | The firm issued product notification letter February 20, 2008, to its consignees. The notification alerts customers to the behavior, requires them to post the notification and notify users not to use the Freehand ROI feature until they are upgraded to a corrected software version. Philips will deliver a software upgrade to correct the problem. |
| Quantity | 3 units |
| Distribution | Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042292 | ISITE PACS Stentor, Inc., Sep 8, 2004 |