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Varian Medical Systems, Inc. Oncology Systems recalls Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX.
Recalled May 22, 2013 · FDA recall Z-1325-2013 · Varian Medical Systems, Inc. Oncology Systems
Hazard
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control. · FDA Class II
Units
3943 units
Sold at
Worldwide distribution - USA (nationwide) including Puerto Rico, and countries of: Algeria, Angola, Australia, Austria, Bahrain, Bangladesh, Belarus, Belguim, Brazil, Bosnia and Hezregovina, Bulgaria, Canada, Chile, China, Columbia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, Frances, French Polynesia, Georgia, Germany, Greece, Gaudaloupe, Gaum, Hong Kong, India, Indonesia, Ireland, Italy, Israel, Latvia, Lithuania, Luxemburg, Japan, Kazarhstan, Kuwait, Lebanon, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morroco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Peru, Phillipines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudia Arabia, Serbia, Singapore, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Syria, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezula, Vietnam, and Zimbabwe.
Description
Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to about 7% before interlock occurs. At maximum asymmetry, this may result in no more than about 3.5% dose deviation from expected at any point in the beam, and may result in minor injury to the patient or slightly decreased local disease control.
Product
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: The Varian High Energy Accelerator is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
Manufacturer(s)
Varian Medical Systems, Inc. Oncology Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →