Z-1444-2008

Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0...

Name: Z-1444-2008 Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0...
Creator: Philips Healthcare Informatics, Inc.
Published: 2008-01-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-01-29 / Terminated / root cause: software

FDA source

Philips Healthcare Informatics, Inc. began a recall of Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system on 2008-01-29. The reason FDA records is "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". 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-1444-2008
Status: Terminated
Initiated: 2008-01-29
Posted: 2008-08-16
Terminated: 2008-09-25
Recalling firm: Philips North America LLC
Product: Philips Medical Systems iSite PACS (Picture Archiving and Communications Systems) version 4.1.17.0 - Radiology Image management system.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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 tag: software
FDA 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 in commerce: 2 units
Distribution: Worldwide Distribution --- USA including states of MN, CO, and PA, and country of Germany.
Product codes and lots: Version 4.1.17.0

Product code LLZ

K063267Class IIIsite Pacs, V 4. XStentor Inc., A Philips Medical Systems Co. / cleared 2006-11-09

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)