Device Recall MOSAIQ Oncology Information System

  • Modèle / numéro de série
    Versions 2.50 and higher
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) including states of: AK, AZ, AR, CA, CO, CT, DE DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, ,MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WI, and WY; and countries of: Antiqua & Barbuda, Australia, Austria, Bahama, Bahrain, Canada, Czech Republic, Germany, Hungary, Saudi Arabia, Sweden, Turkey, & United Kingdom.
  • Description du dispositif
    MOSAIQ Oncology Information System || MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Société-mère du fabricant (2017)
  • Source
    USFDA

4 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Software Version 2.41 and higher
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, and Venezuela.
  • Description du dispositif
    MOSAIQ Oncology Information System || MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
  • Manufacturer
  • Modèle / numéro de série
    All software builds.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US nationwide to AK, AL, AR, AZ, CA, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. ALBANIA, ALGERIA, ANTIGUA AND BARBUDA, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BENIN, BOTSWANA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CUBA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, FINLAND, FRANCE, GABON, GEORGIA, GERMANY, GHANA, GREECE, HONDURRAS, HONG KONG, HUNGARY, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KENYA, LAOS, LIBYA, LITHUANIA, MALAYSIA, MALTA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TUNISIA, TURKEY, UNITED KINGDOM, UKRAINE, VENEZUELA, VIETNAM and ZIMBABWE
  • Description du dispositif
    MOSAIQ Medical Charged-Particle Radiation Therapy System
  • Manufacturer
  • Modèle / numéro de série
    Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
  • Description du dispositif
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. || An image enabled electronic medical record system used for oncology workflow management. || Manufactured by: || Impac Medical Systems || 100 Mathilda Place, 5th floor || Sunnyvale, Ca 94086
  • Manufacturer
  • Modèle / numéro de série
    Part # 10568605
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    International Only Distribution -- Germany and Japan
  • Description du dispositif
    MOSAIQ Oncology Information System || Intended Use : Electronic Patient Records Management
  • Manufacturer