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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Philips Healthcare Informatics, Inc.
Lot Codes / Batch Numbers
all products with software versions 3.5.x
Products Sold
all products with software versions 3.5.x
Philips Healthcare Informatics, Inc. is recalling Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3. due to Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026