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Terminated

Clinac, Trilogy. Trilogy Tx and Novalis Tx Linear Accelerators. Varian Medical Systems, Inc. Oncology Systems Intended for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions in the body where radiation treatment is indicated.

FDA Recall Z-2978-2011 · Posted 2011-08-10

Recalling FirmVarian Medical Systems, Inc. Oncology Systems
Recall StatusTerminated
Product CodeIYE
Date Initiated2011-05-26
Date Terminated2012-07-13
Product Quantity5685

Reason for Recall

On Varian Linear Accelerators where the customer may calibrate the collimator angle position readout in reverse, switching the 90 degree and 270 degree positions.

Firm Action

Varian Medical Systems sent an "Urgent Medical Device Correction-Urgent Field Safety Notice" letter dated May 26, 2011 to all affected customers. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letters identifies the product, describes the problem and provides recommendations. Varian recommends maintenance only be performed by qualified personnel with appropriate training, always verify collimator calibration and anytime a collimator posthion readout calibration is performed, and always verify that the collimator angle is not calibrated in reverse by performing the appropriate checks. For questions contact Varian at (888) 827-4265.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution: Nationwide (USA) Distribution and the countries of; Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Belorussia, Bolivia, Bosnia and Herzegoniva, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Rep., Denmark, D.R. Ecuador, Egypt, Estonia, Finland, France, French Poly., Georgia, Germany, Greece, Guam, Guatemala, H.K., Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macau, Macedonia, Malaysia, Martinique, Mexico, Moldova, Monte Negro, Morocco, Nepal, Netherlands, N.Z., Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, P.R., Qatar, Reunion, Romania, Russia, S.A.,Serbia, Singapore, Slovakia, South Africa, S.K., Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad/Tobago, Tunisia, Turkey, Ukrain, U.A.E., U.K., Uruguay, Venezuela, Vietnam, V.I., and Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100890VARIAN HIGH ENERGY LINEAR ACCELERATORVarian Medical Systems · 2010-07-13K033343TRILOGY RADIOTHERAPY DELIVERY SYSTEMVarian Medical Systems, Inc. · 2003-12-23

Official Source

View FDA Recall →

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

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