Company: Fujifilm Medical System USA, Inc
Date of Enforcement Report: 6/9/04
Class: III
PRODUCT
Fuji Flash IIP and CR-IR346CL Consoles. Recall # Z-0993-04.
REASON
Software: Incorrect measurement of objects within a CR image.
CODE
Versions A09-17 through A11-12.
RECALLING FIRM/MANUFACTURER
Fujifilm Medical System USA, Inc., Stamford, CT, by letter dated May 5, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
2,602 units.
DISTRIBUTION
Nationwide.
