Siemens Medical Solutions, USA, Inc KinetDx 4.0 Ultrasound Image Management System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
KinetDx 4.0 Ultrasound Image Management System.
Brand
Siemens Medical Solutions, USA, Inc
Lot Codes / Batch Numbers
All units with software versions 4.0 and 4.1.
Products Sold
All units with software versions 4.0 and 4.1.
Siemens Medical Solutions, USA, Inc is recalling KinetDx 4.0 Ultrasound Image Management System. due to The cardiologist's report comments may not be retained by the system due to a software bug.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The cardiologist's report comments may not be retained by the system due to a software bug.
Recommended Action
Per FDA guidance
In April 2006, Siemens' field force was issued instructions to visit each customer location and to complete the software upgrades within six months.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026