Company: Fujifilm Medical Systems U.S.A
Date of Enforcement Report: 5/29/02
Class: II
PRODUCT
Synapse Image and Information Management System.
Recall # Z-1045-2.
REASON
Rotated/flipped Images not viewed on the screen may not rotate but left / right markers will be flipped.
CODE
Synapse Image and Information Management System with software versions
2.0.2 and 2.1.1.
RECALLING FIRM/MANUFACTURER
Fujifilm Medical Systems U.S.A., Inc., Stamford, CT, by letter dated April 11, 2002. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
70.
DISTRIBUTION
Nationwide.