Z-1235-06

KinetDx 4.0 Ultrasound Image Management System

Name: Z-1235-06 KinetDx 4.0 Ultrasound Image Management System
Creator: Siemens Medical Solutions, USA, Inc
Published: 2006-04-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2006-04-06 / Terminated / root cause: software

FDA source

Siemens Medical Solutions, USA, Inc began a recall of KinetDx 4.0 Ultrasound Image Management System on 2006-04-06. The reason FDA records is "The cardiologist's report comments may not be retained by the system due to a software bug". 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-1235-06
Status: Terminated
Initiated: 2006-04-06
Posted: 2006-07-13
Terminated: 2007-05-01
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: KinetDx 4.0 Ultrasound Image Management System.
Product code: LLZ System, Image Processing, Radiological
Reason for recall: The cardiologist's report comments may not be retained by the system due to a software bug.
Root cause tag: software
FDA root cause: Other
Action: In April 2006, Siemens' field force was issued instructions to visit each customer location and to complete the software upgrades within six months.
Quantity in commerce: 244
Distribution: Nationwide.
Product codes and lots: All units with software versions 4.0 and 4.1.

Product code LLZ

K041029Class IIKinetdxSiemens Medi Cal Solutions, Inc. / cleared 2004-07-08

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)