Device Recall GE Discovery NM 630

  • Model / Serial
    22002 22017 22018 22015 22009 22008 22005 22001 22014 22003
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: CA, FL, GA, IL, NJ, NY, NC, TX, and WI; and countries of: AUSTRALIA, BELGIUM, CANADA, CHINA, DENMARK, FRANCE, GERMANY, INDIA, ISRAEL, ITALY, KOREA, JAPAN, NETHERLANDS, NORWAY, POLAND, RUSSIAN FEDERATION, SPAIN, SWITZERLAND, UNITED KINGDOM.
  • Product Description
    GE Discovery NM 630 || The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
  • Source
    USFDA