Events

Recall of KinetDx

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions, USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35043
  • Event Risk Class
    Class 3
  • Event Number
    Z-1235-06
  • Event Initiated Date
    2006-04-06
  • Event Date Posted
    2006-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-05-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45184
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, Image Processing, Radiological - Product Code LLZ
  • Reason
    The cardiologist's report comments may not be retained by the system due to a software bug.
  • Action
    In April 2006, Siemens' field force was issued instructions to visit each customer location and to complete the software upgrades within six months.

Device

KinetDx
  • Model / Serial
    All units with software versions 4.0 and 4.1.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    KinetDx 4.0 Ultrasound Image Management System.
  • Manufacturer
    Siemens Medical Solutions, USA, Inc

Manufacturer

Siemens Medical Solutions, USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions, USA, Inc, 400 Morgan Rd, Ann Arbor MI 48108
  • Source
    USFDA