Company:Philips Healthcare Informatics, Inc
Date of Enforcement Report 2/18/2009
Class:ll

PRODUCT
iSite PACS (Picture Archiving and Communications System) Versions 4.1.x up to and including 4.1.51.3. 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. Recall # Z-0948-2009

REASON
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.

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

VOLUME OF PRODUCT IN COMMERCE
40 units

DISTRIBUTION
Italy, Denmark, Germany, Netherlands, Sweden, Spain, Portugal, Switzerland, Spain, Turkey, France, Saudi Arabia, Australia, Thailand, New Zealand, Japan, Brazil