Devices

Device Recall MOSAIQ Oncology Information System

  • Model / Serial
    Versions 2.50 and higher
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Elekta, Inc.
  • 1 Event

Manufacturer

Elekta, Inc.
  • Manufacturer Address
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • Manufacturer Parent Company (2017)
    Elekta AB
  • Source
    USFDA

4 devices with a similar name

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Device Recall MOSAIQ Oncology Information System
  • Model / Serial
    Software Version 2.41 and higher
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Elekta, Inc.
Device Recall MOSAIQ Oncology Information System
  • Model / Serial
    All software builds.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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
  • Product Description
    MOSAIQ Medical Charged-Particle Radiation Therapy System
  • Manufacturer
    Elekta, Inc.
Device Recall MOSAIQ Oncology Information Systems
  • Model / Serial
    Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    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.
  • Product Description
    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
    Impac Medical Systems Inc
Device Recall MOSAIQ Oncology Information System
  • Model / Serial
    Part # 10568605
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Only Distribution -- Germany and Japan
  • Product Description
    MOSAIQ Oncology Information System || Intended Use : Electronic Patient Records Management
  • Manufacturer
    Siemens Medical Solutions USA, Inc