Company:Volcano Corp.,
Date of Enforcement Report 12/8/2010
Class ll:

PRODUCT
Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, including ChromaFlo and Virtual Histology. Recall # Z-0168-2011

REASON
Software defect results in improper image brightness, which may result in introduction of artifacts, which may cause misclassification of results and affect classification of tissue types. This may result in misdiagnosis and inappropriate treatment.

RECALLING FIRM/MANUFACTURER
Volcano Corp., Rancho Cordova, CA, by letter dated June 30, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
79 units

DISTRIBUTION
Nationwide, and the countries of France, Germany, Japan, and the UK