Company: Fujifilm Medical System USA, Inc.,
Date of Enforcement Report:3/222006
Class:Il

PRODUCT
Synapse Software Versions 3.1.0 and 3.1.1 used with the Fuji Synapse PACS, Recall # Z-0622-06

REASON
Image orientation and orientation markers may not match when an image is rotated or flipped when the CT Image is preset..

CODE
Versions 3.1.0 and 3.1.1

RECALLING FIRM/MANUFACTURER
Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated February 3, 2006, firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
82 units

DISTRIBUTION
Nationwide, Canada, Japan, and Germany