Recall Z-1141-2008 ยท LLZ System, Image Processing, Radiological
Philips Healthcare Informatics, Inc.
iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.
| Date | May 8, 2008 (initiated Jan 4, 2008) |
| Status | Terminated |
| Reason | Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor. |
| Root cause | Software design |
| Action | Philips Healthcare Informatics mailed customers notification: Urgent Product Correction regarding FCO#2954704-01/04/08-001-C. Firm released a corrected version of software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the corrected version. |
| Quantity | 197 units |
| Distribution | Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042292 | ISITE PACS Stentor, Inc., Sep 8, 2004 |