Company: Philips Healthcare Informatics, Inc.,
Date of Enforcement Report 11/5/2008
Class:ll

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, Recall # Z-0118-2009

REASON
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 both present and different.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA, by letter dated August 29, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
27 units

DISTRIBUTION
Nationwide, Italy, Germany, Netherlands, Sweden, France, Portugal, Switzerland, Thailand, Japan and Australia