SonoCalc IMT 3.0, a 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.
FDA Recall Z-0713-06 · Posted 2006-04-06
Recalling FirmSonosite, Inc.
Recall StatusTerminated
Product CodeLLZ
Date Initiated2005-10-26
Date Terminated2006-04-10
Product Quantity155 units of the SonoCalc product to about 80 customers/distributors
Reason for Recall
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. Underestimates percentage of stenosis, false negative result.
Firm Action
On October 26, 2005, the company sent their customers a User Guide Addendum that told customers how to verify that the image calibration data was correct.
Root Cause
Other
Distribution Pattern
Nationwide, Kuwait, Mexico, South Africa, Chile, Spain, Japan, Puerto Rico, Australia. A list of 155 cases in which the software was sent out lists medical facilities, physicans, and SonoSite Distributors.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.