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Class 2 Device Recall SonoCalc IMT 3.0 |
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Date Initiated by Firm |
October 26, 2005 |
Date Posted |
April 06, 2006 |
Recall Status1 |
Terminated 3 on April 10, 2006 |
Recall Number |
Z-0713-06 |
Recall Event ID |
34808 |
510(K)Number |
K030223
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Product Classification |
System, Image Processing, Radiological - Product Code LLZ
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Product |
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. |
Code Information |
All SonoCalc IMT version 3.0 |
Recalling Firm/ Manufacturer |
Sonosite, Inc. 21919 30th Dr Se Bothell WA 98021-3904
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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.
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FDA Determined Cause 2 |
Other |
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. |
Quantity in Commerce |
155 units of the SonoCalc product to about 80 customers/distributors |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = LLZ and Original Applicant = SONOMETRIC HEALTH, LLC
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