Z-1141-2008

iSite PACS image management system; Picture Archiving and Communications System; Radiology software package...

Name: Z-1141-2008 iSite PACS image management system; Picture Archiving and Communications System; Radiology software package...
Creator: Philips Healthcare Informatics, Inc.
Published: 2008-01-04
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2008-01-04 / Terminated / root cause: software

FDA source

Philips Healthcare Informatics, Inc. began a recall of iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA... on 2008-01-04. The reason FDA records is "Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in...". 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-1141-2008
Status: Terminated
Initiated: 2008-01-04
Posted: 2008-05-08
Terminated: 2009-10-07
Recalling firm: Philips North America LLC
Product: iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Philips Healthcare Informatics, Foster City, CA 94404.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: Incorrect display of one of the patient's images. This malfunction could cause an image to be incorrectly displayed, for example flipped left to right and anterior to posterior. The original image is still presented in the correct orientation next to the incorrect image when displayed on the monitor.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare Informatics mailed customers notification: Urgent Product Correction regarding FCO#2954704-01/04/08-001-C. Firm released a corrected version of software (iSite PACS v.3.5.69) on January 21, 2008. Firm is scheduling customers to upgrade to the corrected version.
Quantity in commerce: 197 units
Distribution: Worldwide Distribution: USA, United Arab Emirates, Germany, the Netherlands, Denmark, Australia, France, Italy, Belgium, Ireland, Italy, and Canada.
Product codes and lots: iSITE PACS version 3.5x (Versions 3.5 and up to and including 3.5.65): 3.5.0.27, 3.5.0.36, 3.5.36.4, 3.5.38, 3.5.51.0, 3.5.51.02, 3.5.51.05, 3.5.56.0, 3.5.57.1, 3.5.57.2, 3.5.57.3, 3.5.57.4, and 3.5.65.0

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