Company: Sonosite, Inc.
Date of Enforcement Report:4/12/2006
Class:lI
PRODUCT
SonoCalc IMT 3.0, windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS). This software generates a report with the patients intima media thickness (IMT) based on average thickness of the carotid artery, Recall # Z-0713-06
REASON
When SonoCalc IMT 3.0 software is used with the SonoSite 180Plus ultrasound system, the software miscalculates the intima-media-thickness, a measurement of risk for cardiovascular or cerebrovascular events. Under estimates percentage of stenosis, false negative result.
CODE
All SonoCalc IMT version 3.0
RECALLING FIRM/MANUFACTURER
Sonosite, Inc., Bothell, WA, by a User Guide Addendum on October 26, 2005, firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE
155 units
DISTRIBUTION
Nationwide and Internationally
