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.
This recall has been terminated (originally issued April 6, 2006).
- Company
- Sonosite, Inc.
- Recall Initiated
- October 26, 2005
- Posted
- April 6, 2006
- Terminated
- April 10, 2006
- Recall Number
- Z-0713-06
- Quantity
- 155 units of the SonoCalc product to about 80 customers/distributors
- Firm Location
- Bothell, WA
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
All SonoCalc IMT version 3.0
Root Cause
Other
Action Taken
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.