Z-0948-2009

iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3...

Name: Z-0948-2009 iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3...
Creator: Philips Healthcare Informatics, Inc.
Published: 2008-12-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-12-29 / Terminated / root cause: software

FDA source

Philips Healthcare Informatics, Inc. began a recall of iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster... on 2008-12-29. The reason FDA records is "Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report". 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-0948-2009
Status: Terminated
Initiated: 2008-12-29
Posted: 2009-01-30
Terminated: 2010-11-29
Recalling firm: Philips North America LLC
Product: iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3, manufactured by Philips Healthcare Informatics, Foster City, CA. Device is an image management system intended to be used by trained professionals, and 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 image processing, measurement, communication and storage
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Product may display clinical reports with the study date and time in GMT format, which may not be obvious to the end user, who may expect to see the local time in the report.
Root cause tag: software
FDA root cause: Software design
Action: Product notification was issued on 12/29/2008, instructing users to identify affected products, and instructing users to refer to image overlays for local study date and time information. The firm is planning a field correction expected to be available in "Q1 2009". For additional information, contact Philips at 650-293-2624.
Quantity in commerce: 40 units
Distribution: International - Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, and Brazil.
Product codes and lots: Versions 4.1.x up to and including 4.1.51.3

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