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U.S. Department of Health and Human Services

Class 2 Device Recall Eclipse Treatment Planning System version 13.MR2

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  Class 2 Device Recall Eclipse Treatment Planning System version 13.MR2 see related information
Date Initiated by Firm December 02, 2016
Date Posted January 10, 2017
Recall Status1 Terminated 3 on May 12, 2017
Recall Number Z-0990-2017
Recall Event ID 76018
510(K)Number K141283  
Product Classification Accelerator, linear, medical - Product Code IYE
Product Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12]


Radiology: 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.
Code Information Model # H48  Serial numbers: H48L574 H48L575 H48L576 H48L577 H48L578 H48L579 H48L580 H48L581 H48L582 H48L583 H48L584 H48L585 H48L586 H48L587 H482484 H487302 H48A587 H48D957 H480113 H480118 H481884 H481885 H481886 H481916 H481917 H484198 H484199 H488949 H48A680 H48A871 H48A872 H48A873 H48A874 H48A875 H48A876 H48A877 H48A878 H48A879 H48I531 H481195 H481236 H481237. 
Recalling Firm/
Manufacturer		 Varian Medical Systems, Inc.
911 Hansen Way
Palo Alto CA 94304-1028
For Additional Information Contact K. Jeffrey Semone
650-424-6833
Manufacturer Reason
for Recall		 Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled.
FDA Determined
Cause 2		 Device Design
Action Varian Medical Systems sent an Urgent Medical Device Correction Letter dated December 5, 2016 , that were sent to all 5 affected sites on December 5, 2016 by a trackable method. Letters advised users of the issue and the specific scenario that must take place for the issue to occur. Varian is investigating the issue and will provide a correction once it is available. We sincerely apologize for any inconvenience and thank you in advance for your cooperation. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager. This notice has been provided to the appropriate Regulatory Authorities. For further questions please call (650) 424-6833. Varian Oncology Help Desk Contact Information: Phone: +1.888.827.4265 Email: support @varian.com
Quantity in Commerce 42 devices are affected
Distribution US Distribution to the states of : NJ, TN. OR and FL.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = IYE and Original Applicant = VARIAN MEDICAL SYSTEMS, INC.
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