Device Recall Monaco RTP System

Monaco versions 5.10.00 and higher

Radiology Devices

2

No

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

Monaco RTP System || Product Usage: || The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Software 3.1 and higher.

Radiology Devices

2

No

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.

Monaco RTP System || Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Software Versions 5.00 and higher

Radiology Devices

2

No

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

Monaco RTP System || Product Usage: || Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

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

Radiology Devices

2

No

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

Monaco RTP System. || Used to make treatment plans for patients with prescriptions for external beam radiation therapy.

Versions 3.20.00 and 3.20.01

Radiology Devices

2

No

Nationwide Distribution-including the states of AK, CA, FL, NJ, NC, OH, OR, TN, TX, WA, and WI.

Monaco RTP System. || Radiation treatment planning.