Events

Recall of Medtronic 0arm Imaging System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Navigation, 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
    45492
  • Event Risk Class
    Class 2
  • Event Number
    Z-0294-2008
  • Event Initiated Date
    2007-10-17
  • Event Date Posted
    2007-11-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-11-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65617
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
    Imaging System - Product Code JZL
  • Reason
    Reversed instrument position : a defect in the software version 3.0 causes an error in the position of surgical instruments and relative motion are reversed 180' on the stealthstation image. (if the stealthstation is not used, or if the patient orientation is prone or supine, the problem does not occur).
  • Action
    Medtronic Navigation notified customers by letter on October 17, 2007. Medtronic Field service will perform upgrade (software version 3.0.1) at user site.

Device

Medtronic 0arm Imaging System
  • Model / Serial
    System Serial Numbers: 103, 104, 109, 117, 119 (Germany) 125, and 144 (Canada)
  • Product Classification
    Radiology Devices
  • Distribution
    Worldwide: USA including states of CO, IN, NE, and MN and countries of Canada and Germany
  • Product Description
    Medtronic 0-arm Imaging System, Product Catalog Number: B1-700-00027, Medtronic Navigation, Inc., Littleton, MA 01460 || (software version 3.0)
  • Manufacturer
    Medtronic Navigation, Inc

Manufacturer

Medtronic Navigation, Inc
  • Manufacturer Address
    Medtronic Navigation, Inc, 826 Coal Creek Circle, Louisville CO 80027-9710
  • Source
    USFDA