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Terminated

Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Trilogy Radiotherapy Delivery System is a radiation therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are intended for therapy of lesions, e.g., arteriovenous malformations, primary tumors and metastases. Stereotactic treatments may be intracranial or extra cranial and consist of single-session or fractionated delivery.

FDA Recall Z-0886-2011 · Posted 2011-01-08

Recalling FirmVarian Medical Systems Oncology Systems
Recall StatusTerminated
Product CodeGKZ
Date Initiated2010-06-10
Date Terminated2011-12-23

Reason for Recall

The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch.

Firm Action

Varian sent a Customer Technical Bulletin letter to all affected users on May 27, 2010, and was also posted to Varian's customer support site: http://www.MyVarian.com. The letter identified the product, the problem, and provided instructions on the recall. Customers were instructed to return the proof of notification (via completed "Proof of Notification Form or appropriate Postal system certified receipt of delivery to Varian. For questions regarding this recall call 650-483-3153.

Root Cause

Other

Distribution Pattern

Worldwide Distribution - USA including CA, TX, IL, GA, NJ, and NV and the countries of Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Italy, Japan, Middle East, Netherlands, Russia, Spain, Switzerland, and the UK

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K070094TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEMVarian Medical Systems, Inc. · 2007-02-09K913119VARIAN C-SERIES CLINACS (CLINAC 2300C/D)Varian Assoc., Inc. · 1991-11-07K904364VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500CVarian Assoc., Inc. · 1991-02-27

Official Source

View FDA Recall →

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

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