Company:Fujifilm Medical System USA, Inc.
Date of Enforcement Report: 6/25/03
Class: II
PRODUCT
Synapse. Recall # Z-0932-03.
REASON
Synapse Version 2.2.1 and 2.3.1software (Free-Hand Region) may lead to incorrect density calculations during CT scan.
CODE
Version 2.2.1 and 2.3.1.
RECALLING FIRM/MANUFACTURER
Fujifilm Medical System USA, Inc., Stamford, CT, by letter during the week of May 12, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
54 units.
DISTRIBUTION
Nationwide, Canada, Germany, Isrel, and Japan.
