Z-0118-2009

iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is...

Name: Z-0118-2009 iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is...
Creator: Philips Healthcare Informatics, Inc.
Published: 2008-08-29
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-08-29 / Terminated / root cause: software

FDA source

Philips Healthcare Informatics, Inc. began a recall of iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package)... on 2008-08-29. The reason FDA records is "Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and...". 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-0118-2009
Status: Terminated
Initiated: 2008-08-29
Posted: 2008-10-28
Terminated: 2010-11-30
Recalling firm: Philips North America LLC
Product: iSite PACS (Picture Archiving and Communication System), software versions 3.6.28.x and 4.1.x. The product is an image management system (software package) used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Device is intended for use by trained professionals.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Two defects have been identified: 1) potential to display a patient on the canvas page that is different from the patient whose images are displayed on diagnostic monitors when using Conference Presentation States and when opening two or more studies from a folder or an exam worklist and 2) potential to miscalculate measurements when Pixel Spacing and Imager Pixel Spacing DICOM tag values are bot
Root cause tag: software
FDA root cause: Software design
Action: A notification letter (Urgent Product Correction) dated 8/29/08 was sent via certified mail to all customers alerting them of the issue, requiring posting of notification. Philips Healthcare Informatics, Inc. strongly recommend all customers advise their iSite Radiology users not to open multiple patient exams simultaneously from a folder or worklist using Conference Presentation States. A software correction is being worked on, and should be available by end of Q3 2008 for version 4.1.45.2. A mandatory upgrade is required for all customers who are currently using iSite version 4.1.45.2 and former versions. For specific questions regarding these issues, contact the Customer Advocate (CARE) or Customer Care at Philips Healthcare Informatics, Inc. at 1-877-328-2808. In your communication with Customer Care at Philips Healthcare Informatics, Inc. , please refer to this notification and associated FCO 22945704-08292008-004.
Quantity in commerce: 27 units.
Distribution: Worldwide Distribution including USA (MN, CO and PA) and countries of Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia.
Product codes and lots: Software versions 3.6.28.x and 4.1.x.

Product code LLZ

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)