Events

Recall of Device Recall InstaTrak 3500 Plus

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
    37661
  • Event Risk Class
    Class 2
  • Event Number
    Z-0181-2008
  • Event Initiated Date
    2007-03-23
  • Event Date Posted
    2007-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51247
  • 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 Radiological System - Product Code LLZ
  • Reason
    Tracking accuracy - image intensifier supplier's change on the c-arm could lead to patient injury, due to incorrect anatomical location of the instrument during a procedure.
  • Action
    Consignees were sent an Urgent Recall Notice letter, via mail dated 10/11/07, advising users to stop usage of the FluoroTrak and FluoroCAT spinal applications on the InstaTrak 3500 Plus System. Once a solution is identified, a representative will contact consignees to arrange for installation of the solution at no charge.

Device

Device Recall InstaTrak 3500 Plus
  • Model / Serial
    Serial numbers: IT35052, IT35070, IT35108, IT35109, IT35129, IT35130, IT35132, IT35133, IT35134, IT35139, IT35146, IT35152, IT35166, IT35169P-RC-1, IT35173, IT35179P, IT35181, IT35185P-G-RC, IT35187P, IT35189P, IT35193P, IT35214P, IT35216P, IT35223P, IT35225P, IT35226P, IT35234P, IT35244P, IT35245P, IT35251P, IT35269P, IT35280P, IT35286P, IT35289P, IT35292P, IT35293P, IT35296P, IT35299P, IT35301P, IT35302P, IT35304P, IT35311P, IT35312P, IT35316P, IT35323P, IT35324P, IT35330P, IT35339P, IT35344P, IT35375P, IT35377P, IT35379P, IT35381P, IT35382P, IT35383P, IT35406G, IT35435G, IT35458G, IT35468G.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class II Recall - Worldwide Distribution - USA including states of AZ, CA, FL, GA, IA, IL, KS, LA, MA, MD, MI, NC, NY, OK, PA, SC, TX, UT, VA, and WI, and countries of Canada, China, Germany, Hong Kong, Italy, Japan, Mexico, and Spain.
  • Product Description
    GE OEC, InstaTrak 3500 Plus FluoroTrak and Fluoro CAT Spinal Applications used with Regular and Super 9800 and 9600 Arm Systems. GE Health Medical Systems, Inc, Salt Lake City, UT 84116-2862
  • 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