Device Recall Monaco

  • Modèle / numéro de série
    Version 3.10.00
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including the states of OH, IN, WI, CA, FL, IL, LA, NJ, MA, NC, and MO and the countries of Canada, Australia, Belgium, China, France, Germany, Japan, The Netherlands, New Zealand, Portugal, Switzerland, Taiwan, and the United Kingdom.
  • Description du dispositif
    Monaco Radiation Treatment Planning System, Version 3.10.00. || Planning of radiation therapy.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Computerized Medical Systems Inc, 13723 Riverport Dr Ste 100, Maryland Heights MO 63043-4819
  • Société-mère du fabricant (2017)
  • Source
    USFDA

13 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Monaco Release 3.30 and higher
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AK, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MT, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA and WI., and to the countries of Angola, Argentina, Austria, Australia, Bangladesh, Belgium, Bulgaria, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Algeria, Ecuador, Spain, Finland, France, Great Britain, Greece, Hong Kong, Ireland, Israel, India, Iraq, Italy, Jordan, Japan, South Korea, Kazakhstan, Sri Lanka, Lithuania, Libya, Morocco, Myanmar, Malta, Mexico, Malaysia, Namibia, Nicaragua, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Turkey, Taiwan, Venezuela and South Africa.
  • Description du dispositif
    Monaco radiation therapy treatment planning system. || The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
  • Manufacturer
  • 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
  • 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
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