Recall Z-0713-06 ยท LLZ System, Image Processing, Radiological
Sonosite, Inc.
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.
| Date | Apr 6, 2006 (initiated Oct 26, 2005) |
| Status | Terminated |
| 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030223 | SONOCALC Sonometric Health, LLC, Feb 6, 2003 |