Device Recall Monaco RTP system

  • Modèle / numéro de série
    Monaco versions 5.10.00 and higher
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cyprus, Czech Republic, Ecuador Egypt, Estonia, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Morocco, Nabibia, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka,Sweden, Switzerland, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Zimbabwe
  • Description du dispositif
    Monaco RTP System || Product Usage: || The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • 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

7 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Software 3.1 and higher.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, to the states of AK, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MN, MO, MT, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antigua and Barbuda, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Nambia, Nepal, Netherlands, New Zealand, Nicaragua, 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, Turkey, United Kingdom, Ukraine, Venezuela, Vietnam, and Zimbabwe.
  • Description du dispositif
    Monaco RTP System || Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
  • Modèle / numéro de série
    Software Builds 5.11 and 5.20
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AK, AZ, CA, CO, FL, GA, IL, IN, MA, MI, MN, MO, NV, NH, NY, NC, OH, OK, OR, PA, SD, TX, UT, VA, WA, WI, Algeria, Australia, Austria, Brazil, Canada, China, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Laos, Malaysia, Mexico, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela,
  • Description du dispositif
    Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
  • Modèle / numéro de série
    Software Versions 5.00 and higher
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the state of CA, IN, KY, MA, NJ, NY, NC, PA, TX, WI, and the countries of Brazil, Canada, China, Croatia, Estonia, Germany, India, Japan, Netherlands, New Zealand, Norway, Poland, Serbia, South Africa, Spain, Russia, Turkey
  • Description du dispositif
    Monaco RTP System || Product Usage: || Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
  • Modèle / numéro de série
    Software Builds - V 5.10.00 (including 5.10.01, 5.10.02); V 5.11.00 (including 5.11.01); V 5.20.00
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AZ, AR, CA, CO, CL, GA. IL, IN, LA, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SD, TX, UT, VA, WA, WI, Puerto Rico, Algeria, Antiqua & Barbuda, Argentina, Australia, Austria, Bangladesh, Bahrain, Belarus, Botswana, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cuba, Cyprus, Czech Republic, Ecuador, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Laos, Lithuania, Malaysia, Malta, Mexico, Morocco, Myanmar, Napal, Namibia, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Peru, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Switzerland, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Venezuela, Vietnam, Zimbabwe
  • Description du dispositif
    Monaco RTP System. || Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
  • Modèle / numéro de série
    Versions 3.20.00 and 3.20.01
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
  • Description du dispositif
    Monaco RTP System. || Radiation treatment planning.
  • Manufacturer
2 en plus