Worldwide Distribution - USA (Nationwide) and countries of: Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Malaysia, Mexico Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab E, and United Kingdom.
Description du dispositif
Varian brand RPM Respiratory Gating System, RPM Gating v1.7.5 with 3D Option, Model Number: HS2 || Product Usage: The RPM device is to be used to characterize the patients respiratory motion information to synchronize their operation with the respiratory motion.
Product was released for distribution to 7 hospitals in the US. Distribution was limited to the following States: CA, MA, NC, SC, PA, and LA. 1 (one) Canadian distribution includes Fraser Valley Cancer Center, Dept. of Radiation Oncology, 13750 96th Ave., Surrey, BC, V3V 1Z2, Canada. Foreign distribution includes Austria, Germany and Finland. The recall was appropriately extended to the user level; i.e., the hospitals/physicians who received the recalled product.
Description du dispositif
VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x
Worldwide Distribution -- USA (nationwide) and countries of: Australia, Columbia, Denmark, France, Ireland, Italy, Japan, Morocco, Poland, Portugal, Saudi Arabia, South Korea, Spain, and United Kingdom.
Description du dispositif
Clinac Linear Accelerator; || Model numbers H14, H27 and H29. || Product Usage: Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
Varian High Energy Linear Accelerator, C-Series Clinac, Reference/FSCA Identifier: CP-06611; Models Numbers: 600C, 600CD, 6EX, DBX, 2100C, 2100CD, 2300CD, 21EX, 23EX, DMX, DHX versions 2.x through 6.x; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. || The Varian High Energy Linear Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Worldwide Distribution: Nationwide distribution including the states of AZ, CA, FL, GA, IN, MA, MD, MI, MN, MO, NJ, NY, PA, SC, TN, VA and WV; and the countries of Canada, Austria, Belgium, Brazil, Denmark, Finland, France, Germany, India, Ireland, Italy, Lithuania, Poland, Portugal, Romania, South Africa, South Korea, Spain, Sweden, Switzerland and UK.
Description du dispositif
Varian Treatment version 6.6.5052. || Varian Medical Systems, || Palo Alto, Ca || Intended to provide accurate treatment set-ups for each patient by monitoring linear accelerator set-up parameters and by preventing the radiation therapy device form commencing irradiation while any linear accelerator parameter is out of conformance with the treatment plan.