SonoCalc IMT 3.0, a windows based software used in conjunction with images from high-resolution ultrasound systems (Micr
FDA device recall Z-0713-06 · posted 2006-04-06 · Terminated
Recall details
- Recalling firm
- Sonosite, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LLZ
- Quantity affected
- 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 Distribu
- Date initiated
- 2005-10-26
- Date posted
- 2006-04-06
- Date terminated
- 2006-04-10
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SONOCALC (K030223) | Sonometric Health, LLC | 2003-02-06 |