Devices

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
  • 1 Event

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

2 devices with a similar name

Learn more about the data here

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
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