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U.S. Department of Health and Human Services

Class 2 Device Recall Eclipse Treatment Planning System

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 Class 2 Recall
Eclipse Treatment Planning System
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on June 06, 2014
Recall Number Z-0370-2012
Recall Event ID 60441
Premarket Notification
510(K) Number
K091492 
Product Classification System,Planning,Radiation Therapy Treatment - Product Code MUJ
Product Varian brand Eclipse Release 10 with RT Chart Release 10 (Client Build 10.0.28 or Build 10.0.34), An Eclipse Treatment Planning System used with ARIA Radiation Oncology (RT Chart module), Reference/FSCA Identifier: CP-05277, Model Number: H48; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Code Information CODES: All codes from H480005 through H48C896
Recalling Firm/
Manufacturer
Varian Medical Systems, Inc. Oncology Systems
911 Hansen Way
Palo Alto, California 94304-1028
For Additional Information Contact Peter J. Coronado
650-424-5731
Manufacturer Reason
for Recall
An anomaly has been identified with Varian Eclipse and RT Chart where adding a reference point in RT Chart and editing the field dose contributions may change the Prescribed Dose Per Fraction in Eclipse.
FDA Determined
Cause 2
DESIGN: Device Design
Action Varian Medical Systems sent an "URGENT MEDICAL DEVICE CORRECTION/URGENT FIELD SAFETY NOTICE" dated October 31, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Varian has corrected the issue and will contact customers to schedule installation of the corrected version of the system. Contact the Varian Oncology Help Desk at 1-888-827-4265 for questions regarding this notice. .
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MUJ and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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