Company: Philips Healthcare Informatics, Inc.,
Date of Enforcement Report 5/14/2008
Class:lll

PRODUCT
iSite PACS image management system; Picture Archiving and Communications System; Radiology software package, Recall # Z-1141-2008

REASON
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.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Informatics, Inc., Foster City, CA, by letter on January 21, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
196 units

DISTRIBUTION
Nationwide and Internationally