Device Recall Tec 6 Plus Vaporizer

  • 모델명 / 제조번호(시리얼번호)
    Part Numbers: X1107-9001-000, X1107-9002-000, X1107-9003-000, X1107-9004-000, X1107-9005-000, X1107-9006-000, X1107-9007-000, X1109-9008-000, X1109-9009-000, X1107-9010-000, X1107-9011-000, X1107-9012-000, X1107-9014-000, X1107-9015-000, X1107-9016-000, X1107-9101-000, X1107-9102-000, X1107-9103-000, X1107-9201-000, X1107-9202-000, X1107-9203-000, X1107-9205-000, X1107-9206-000, X1107-9601-000, X1107-9602-000, X1107-9603-000, X1107-9604-000, X1107-9605-000, X1107-9606-000, X1107-9607-000, X1107-9608-000, X1107-9609-000, X1107-9610-000, X1107-9611-000, X1107-9612-000, X1107-9614-000, X1107-9615-000, X1107-9616-000, X1107-9617-000, M1145610-X, M1220023-X, M1220854-X, M1221495-X, 2064455-X, M1243207-X, X1107-9701-000, X1107-9702-000, X1107-9703-000, X1107-9211-000, X1107-9212-000, X1107-9213-000, X1107-9215-000, X1107-9216-000, X1107-9217-000, X1107-9207-000, X1107-9208-000, 2066725-X, 2066835-X, 2069767-X, 1107-9601-000, 1107-9612-000, M1221495, M1220023, M1243207, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9605-000, 1107-9606-000, 1107-9607-000, 1107-9608-000, 1107-9609-000, 1107-9610-000, 1107-9611-000, 1107-9614-000, 1107-9615-000, 1107-9616-000, 1107-9617-000, M1145610, M1220854, 2064455-001, M1098876, 2066725-001, 2066835-001, 2069767-001, X1107-8003-000, X1107-8006-000, X1107-8007-000, X1107-8008-000, X1107-8012-000, X1107-8013-000, X1107-8014-000, X1107-8015-000, X1107-8016-000, X1107-8017-000, X1107-8018-000, X1107-8019-000
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Puerto Rico and internationally to AUSTRALIA, AUSTRIA, BAHAMAS, BAHRAIN, BELGIUM, BOLIVIA, BRAZIL, CANADA, CHILE, CHINA, COSTA RICA, CROATIA local name-Hrvatska, CYPRUS, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, KOREA-REPUBLIC OF, KUWAIT, LITHUANIA, MALAYSIA, MALTA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PAKISTAN, POLAND, PORTUGAL, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, and VENEZUELA,
  • 제품 설명
    Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped with the proprietary Selectatec manifold. The Tec 6 Plus NAD Variant attaches only to NAD anesthesia machines equipped with the NAD exclusion type manifold.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • 제조사 모회사 (2017)
  • Source
    USFDA