Recalls / —

—#45184

Product

KinetDx 4.0 Ultrasound Image Management System.

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K041029

Affected lot / code info

All units with software versions 4.0 and 4.1.

Why it was recalled

The cardiologist's report comments may not be retained by the system due to a software bug.

Root cause (FDA determination)

Other

Action the firm took

In April 2006, Siemens' field force was issued instructions to visit each customer location and to complete the software upgrades within six months.

Recalling firm

Firm

Siemens Medical Solutions, USA, Inc

Address

400 Morgan Rd, Ann Arbor, Michigan 48108

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2006-04-06

Posted by FDA

2006-07-13

Terminated

2007-05-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #45184. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.