Events

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
    Recall
  • Event ID
    31133
  • Event Risk Class
    Class 2
  • Event Number
    Z-0711-05
  • Event Initiated Date
    2005-01-28
  • Event Date Posted
    2005-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-04-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37209
  • 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.

Device

Device Recall Stereotaxic Navigation System
  • Model / Serial
    Catalog Numbers: 960-201 and 9730888. Cranial Application software v.4.5.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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
    Medtronic Surgical Navigation Technologies, Inc

Manufacturer

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