Device Recall Monaco RTP System

  • 모델명 / 제조번호(시리얼번호)
    Software Builds 5.11 and 5.20
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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,
  • 제품 설명
    Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Elekta, Inc., 400 Perimeter Center Ter NE Ste 50, Atlanta GA 30346-1227
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 7 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Monaco versions 5.10.00 and higher
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    Monaco RTP System || Product Usage: || The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Software 3.1 and higher.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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.
  • 제품 설명
    Monaco RTP System || Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Software Versions 5.00 and higher
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    Monaco RTP System || Product Usage: || Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    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
  • 제품 설명
    Monaco RTP System. || Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Versions 3.20.00 and 3.20.01
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.
  • 제품 설명
    Monaco RTP System. || Radiation treatment planning.
  • Manufacturer
하나 더 2 건 더