Recall of Device Recall Stereotaxic Navigation System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Surgical Navigation Technologies, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Neurological Stereotaxic Instrument - Product Code HAW
  • Reason
    The stealth station cranial application version 4.5 contains a software anomaly, which may present a hazard to the patient.
  • Action
    Customers were sent notification letters dated 01/28/05 and 02/02/05.


  • Model / Serial
    Catalog Numbers: 960-201 and 9730888. Cranial Application software v.4.5.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Domestic distribution: FL, CO, AZ, TX, AR, MT, OK, IL, PA, NY, LA, WI, NC, ND, CA, GA, AL, OR, WY, WA, OH, NV. Foreign distribution: Belgium, Czech Republic, China (Malaysia). No military or VA facilites.
  • Product Description
    Stealth Station Cranial Application v.4.5
  • Manufacturer


  • Manufacturer Address
    Medtronic Surgical Navigation Technologies, Inc, 826 Coal Creek Cir, Louisville CO 80027-9710
  • Source