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Terminated

C-Series: Clinac, Trilogy, Trilogy Tx. , Novalis high energy linear accelerators and UNIQUE single energy linear accelerator; Versions 7, 8 and 9. The UNIQUE is not sold in the US. Product Usage: The Varian High Energy Linear Accelerator is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. The UNIQUE is a single energy medical linear accelerator. UNIQUE is indicated for precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.

FDA Recall Z-0439-2014 · Posted 2013-12-03

Recalling FirmVarian Medical Systems, Inc.
Recall StatusTerminated
Product CodeIYE
Date Initiated2013-10-24
Date Terminated2016-01-13
Product Quantity3,809 devices

Reason for Recall

This correction is to notify users that a solution to a previous correction has been developed and Varians reps will be contacting locations to schedule installation.

Firm Action

Varian sent an Urgent Medical Device Correction letter, P/N CP-05645 Rev D dated October 24, 2013 to their affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated all affected sites will be contacted by Varian representatives to schedule an upgrade to their devices. Questions may be directed to 888-827-4265 for USA and Canada. Europe +41 41 749 8844

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - USA Nationwide and in the countries of Algeria, Angola, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belgium, Belorussia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Uthuania, luxembourg, Macau, Macedonia, Malaysia, Martinique, Mauritania, Mexico, Moldova, Monaco, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, SriLanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Vietnam, and Zimbabwe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132705UNIQUEVarian Medical Systems, Inc. · 2013-10-31K131807HIGH ENERGY LINEAR ACCELERATORVarian Medical Systems, Inc. · 2013-10-11

Official Source

View FDA Recall →

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

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