Company: Philips Healthcare Informatics, Inc
Date of Enforcement Report 11/5/2008
Class:ll
PRODUCT
Philips Healthcare Informatics iSite PACS (Picture Archiving and Communications System), version 3.5.x. The system 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 imaging, measurement, communication and storage, Recall # Z-2346-2008
REASON
Scout line and localizer crosshair on MPR images will display in the incorrect position under certain circumstances.
RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA, by letter on July 3, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
198 units
DISTRIBUTION
Nationwide, Canada, UAE, UK, New Zealand, Netherlands, Germany, France, Denmark, Belgium, and Austria