Devices

Device Recall CT/e and HiSpeed X/i computed Tomography systems

  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- UNITED STATES (AL, AZ, AR, CA, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MA, MI, LMN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, PA, PR,SC, SD, TN, TX, VA, WA, WV and WI), ALGERIA, ANTIGUA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BENIN, BOLIVIA, BOSNIA & HERZEGOVINIA, BRAZIL BULGARIA, BYELORUSSIAN, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK , DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COST, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, , MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITANIA, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGER, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIAN F=FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND , SYRIA ARAB REPUBLIC, TAIWAN, THAILAND, TRINIDAD & TOBAGO TUNISIA, TURKEY,, UGANDA, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN and YUGOSLAVIA.
  • 제품 설명
    GE Healthcare CT/e and HiSpeed X/i, families of computed tomography Systems with Gantry. || The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.
  • Manufacturer
    GE Medical Systems, LLC
  • 1 Event

제조사

GE Medical Systems, LLC
  • 제조사 주소
    GE Medical Systems, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
    General Electric Company
  • Source
    USFDA

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Device Recall CT/e and HiSpeed X/i computed Tomography systems
  • 모델명 / 제조번호(시리얼번호)
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  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- UNITED STATES (AL, AZ, AR, CA, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MA, MI, LMN, MS, MO, NE, NJ, NM, NY, NC, OH, OK, PA, PR,SC, SD, TN, TX, VA, WA, WV and WI), ALGERIA, ANTIGUA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BELGIUM, BENIN, BOLIVIA, BOSNIA & HERZEGOVINIA, BRAZIL BULGARIA, BYELORUSSIAN, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK , DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COST, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, , MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITANIA, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NICARAGUA, NIGER, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL QATAR, ROMANIA, RUSSIAN F=FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAK IA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND , SYRIA ARAB REPUBLIC, TAIWAN, THAILAND, TRINIDAD & TOBAGO TUNISIA, TURKEY,, UGANDA, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM, YEMEN and YUGOSLAVIA.
  • 제품 설명
    Sytec 6000, Sytec 8000, and Lemage/ProSeed/ProSpeed families. || The CT/e and HiSpeed X/i families CT Scanner Systems are indicated for head and whole body X-ray Computed Tomography applications.
  • Manufacturer
    GE Medical Systems, LLC