Company:Volcano Corp.
Date of Enforcement Report 2/15/12
Class ll:
PRODUCT
Volcano pcFM Software Kit. The volcano pcFM Software Kit is a research only off line tool intended for review and printout of physiological measurements recorded by ComboMap System. It is not intended for analysis or manipulation of the original measurement data. Model 6830 ComboMap Software kit; Kit. Recall # Z-0973-2012
REASON
Internal review of validation of pcMF Software kit found that instructions directs user to remove the rear panel, causing the potential for electric shock.
RECALLING FIRM/MANUFACTURER
Volcano Corp., Rancho Cordova, CA, by letter dated June 17, 2010. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Nationwide, The Netherlands, Sweden and United Kingdom
