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U.S. Department of Health and Human Services

Class 2 Device Recall SonoCalc IMT 3.0

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 Class 2 Device Recall SonoCalc IMT 3.0see related information
Date Initiated by FirmOctober 26, 2005
Date PostedApril 06, 2006
Recall Status1 Terminated 3 on April 10, 2006
Recall NumberZ-0713-06
Recall Event ID 34808
510(K)NumberK030223 
Product Classification System, Image Processing, Radiological - Product Code LLZ
ProductSonoCalc 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.
Code Information All SonoCalc IMT version 3.0
FEI Number 3002087856
Recalling Firm/
Manufacturer		 Sonosite, Inc.
21919 30th Dr Se
Bothell WA 98021-3904
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionOn 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.
Quantity in Commerce155 units of the SonoCalc product to about 80 customers/distributors
DistributionNationwide, 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = LLZ
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