Device Recall Sensor cables

  • Model / Serial
    All serial numbers.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NY, OH, OR, PA, RI, SC, SC, TN, TX, UT, VA, VT, WA, WI and WV and the countries of Austria, Canada, China, Denmark, England, France, Germany, Hong Kong, India, Ireland, Italy, Japan, San Salvador, Slovakia, Spain, and Switzerland.
  • Product Description
    Receiver Sensor Cables, Part Numbers: 1001989, 1001990, 1004069, 1007907-NAV, GE Healthcare Surgery, Salt Lake City, UT 84116. || Cables are used with InstraTrak Navigation Systems, Models IT3000, IT2500, IT2500+, IT3500, IT3500+. InstaTrak System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, visible on medical images such as CT, MR, or X-ray.
  • Manufacturer
  • 2 Events

Manufacturer

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