Z-0713-06

SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound...

Name: Z-0713-06 SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound...
Creator: Sonosite, Inc.
Published: 2005-10-26
License: https://open.fda.gov/license/

FUJIFILM SonoSite,Inc. / initiated 2005-10-26 / Terminated / root cause: software

FDA source

Sonosite, Inc. began a recall of SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (MicroMaxx, TITAN, and SonoSite180PLUS)... on 2005-10-26. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0713-06
Status: Terminated
Initiated: 2005-10-26
Posted: 2006-04-06
Terminated: 2006-04-10
Recalling firm: FUJIFILM SonoSite,Inc.
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.
Product code: LLZ System, Image Processing, Radiological
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.
Root cause tag: software
FDA 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 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.
Product codes and lots: All SonoCalc IMT version 3.0

Product code LLZ

K030223Class IISonocalcSonometric Health, LLC / cleared 2003-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)