Events

Recall of Device Recall InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM

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
    66992
  • Event Risk Class
    Class 2
  • Event Number
    Z-0524-2014
  • Event Initiated Date
    2013-11-26
  • Event Date Posted
    2013-12-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124446
  • 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
    Ge oec medical systems inc is recalling instatrak¿ 3500 plus, entraktm plus, instatrak¿ 3500, entraktm computer-assisted navigation systems (usa) due to several potential safety issues related to the use of these products.
  • Action
    GE Healthcare sent an An Urgent Medical Device Correction letter dated November 26, 2013, to all affected customers. The letter identified the product, the problem, and provided instructions for immediate mitigation of the issue. No product is being returned. The affected systems in the field will be corrected. Customers with questions were instructed to contact the service team at 800-874-7378. For questions regarding this recall call 801-536-4952.

Device

Device Recall InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM
  • Model / Serial
    Model Numbers IT2500,IT2500 Plus,IT3500, IT3500 Plus
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
  • 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