Events

Recall of SonoCalc IMT 3.0

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sonosite, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    34808
  • Event Risk Class
    Class 2
  • Event Number
    Z-0713-06
  • Event Initiated Date
    2005-10-26
  • Event Date Posted
    2006-04-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44741
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Image Processing, Radiological - Product Code LLZ
  • 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. underestimates percentage of stenosis, false negative result.
  • 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.

Device

SonoCalc IMT 3.0
  • Model / Serial
    All SonoCalc IMT version 3.0
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Sonosite, Inc.

Manufacturer

Sonosite, Inc.
  • Manufacturer Address
    Sonosite, Inc., 21919 30th Dr Se, Bothell WA 98021-3904
  • Source
    USFDA