Events

Recall of Device Recall Navigation and Visualization System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems,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
    31057
  • Event Risk Class
    Class 2
  • Event Number
    Z-0815-05
  • Event Initiated Date
    2004-07-12
  • Event Date Posted
    2005-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37376
  • 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
    Navigation inaccuracy may result if the headset registration method is used with the axcess system kit.
  • Action
    Customers were notified by letter on 07/12/04.

Device

Device Recall Navigation and Visualization System
  • Model / Serial
    Axcess System Kit P/N: 1005869-001
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic distribution: VA, CT, KY, NJ, LA, PA, TN, OK, CA. Foreign distribution to Germany. There were no military or VA facilities.
  • Product Description
    InstaTrak 3500 Plus Navigation and Visualization System
  • Manufacturer
    GE OEC Medical Systems,Inc

Manufacturer

GE OEC Medical Systems,Inc
  • Manufacturer Address
    GE OEC Medical Systems,Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA