Events

Recall of Device Recall InstaTrak 3500 Plus 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
    31058
  • Event Risk Class
    Class 2
  • Event Number
    Z-0704-2007
  • Event Initiated Date
    2005-01-26
  • Event Date Posted
    2007-03-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37076
  • 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
    Image Processing system-Radiological - Product Code LLZ
  • Reason
    Tracking inaccuracy of 5-10 mm may result when the shunt guide accessory is used with version 5.1 software.
  • Action
    Consignees were visited by GE personnel to upgrade the software, beginning in April, 2004, to version 5.2

Device

Device Recall InstaTrak 3500 Plus system
  • Model / Serial
    InstaTrak 3500 Plus systems with version 5.1 software.   The accessory involved: Shunt Guide (P/N 1004362) when used with version 5.1 software.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- USA including states of AK, AZ, AL, CA, CT, IA, IL, MD, ME, MO, MT, MS, NC, NJ, NY, OH, PA, RI, SD, UT, TX, VA, WA and WI and countries of France, United Kingdom, Japan, Italy, India and Canada
  • Product Description
    InstaTrak 3500 Plus system with cranial application (aid to the surgeon for locating anatomical structures in the human body)
  • 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