19
Apr
2006

Inc., Class II Sonosite

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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