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Terminated

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.

FDA Recall Z-1325-2013 · Posted 2013-05-15

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-05-31
Date Terminated2013-05-15
Product Quantity3943 units

Reason for Recall

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.

Firm Action

Varian sent a Customer Technical Bulletin to all affected customers. The bulletin identified the affected product, problem and actions to be taken. For questions, issues, or concerns contact Varian at 1-888-827-4265 or go to http://my.varian.com

Root Cause

Process design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100890VARIAN HIGH ENERGY LINEAR ACCELERATORVarian Medical Systems · 2010-07-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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