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Terminated

Varian brand C Series Clinics (Includes Trilogy, and Novalis Tx), Model Numbers: H14, H26, H27, H29, Distributed by and/or Manufactured by: Varian Medical Systems Inc., Palo Alto, CA The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room. Intended use: The Trilogy Mx" System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. 7/9/2013 - UPDATE: Determined that the correction only applied to C3 users, not C1 and C2 users.

FDA Recall Z-1001-2011 · Posted 2011-01-31

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2009-12-01
Date Terminated2012-03-14
Product Quantity4411

Reason for Recall

A circuit design anomaly whereby a faulty balance potentiometer can lead to an undetected electron beam asymmetry.

Firm Action

The firm, Varian Medical Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated December 1, 2009 via Federal Express to consignees/customers. The letter described the product, problem and actions to be taken by the customers and the firm. The customers were instructed to perform a verification of field symmetry on electron beam energies to determine the threshold and report any field symmetry issues to their local Varian service office for attention. The firm, Varian, is developing new functionality to detect the symptoms of this component failure condition under all conditions of electron beam operations and asserting a beam interlock if it is detected. Note: Varian indicated until the solution can be developed, they will conduct an audit of installed Clinacs to identify those the suspect "blue" electron beam balance potentiometers installed, and will execute a program of prophylactic replacement of these potentiometers. If you require further clarification, please contact your local Varian Customer Support District or Regional Manager at phone: USA and Canada-1-888-VARIANS (888-827-4265); Europe- +41 41 749-8844 or email [email protected]; North America: [email protected]; Australia/New Zealand: [email protected]; South East Asia: [email protected]; China/Asia: [email protected]; Japan: [email protected]; Latin America: [email protected]; Internet: Oncology Systems - www.myvarian.com; Varian Medical Systems -www.varian.com

Root Cause

Device Design

Distribution Pattern

USA and countries including: Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bolivia, Brazil, Canada, Chile,, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France,French Polynesia, Germany, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Lebanan, Luxembourg, Maca, Macedonia, Malaysia, Martinique, Mexico, Moldova, Morocco, Nepal, Netherlands, New Zealand, Norway, Oman, Pakistan,, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea,, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Uruguay..

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092871TRILOGY MXVarian Medical Systems, Inc. · 2009-11-30K072916TRILOGY SYSTEM WITH RAPIDARCVarian Medical Systems, Inc. · 2007-11-09

Official Source

View FDA Recall →

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

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