Z-2346-2008

Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The...

Name: Z-2346-2008 Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The...
Creator: Philips Healthcare Informatics, Inc.
Published: 2008-07-03
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-07-03 / Terminated / root cause: software

FDA source

Philips Healthcare Informatics, Inc. began a recall of Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x The system is a software package used with general... on 2008-07-03. The reason FDA records is "Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2346-2008
Status: Terminated
Initiated: 2008-07-03
Posted: 2008-09-18
Terminated: 2009-10-07
Recalling firm: Philips North America LLC
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.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.
Root cause tag: software
FDA 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 in commerce: 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
Product codes and lots: all products with software versions 3.5.x

Product code LLZ

K042292Class IIIsite PacsStentor, Inc. / cleared 2004-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)