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U.S. Department of Health and Human Services

Class 2 Device Recall Eclipse(TM) Treatment Planning System

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  Class 2 Device Recall Eclipse(TM) Treatment Planning System see related information
Date Initiated by Firm December 26, 2018
Create Date January 24, 2019
Recall Status1 Terminated 3 on March 10, 2021
Recall Number Z-0771-2019
Recall Event ID 81912
510(K)Number K170969  K172163  K181145  
Product Classification System, planning, radiation therapy treatment - Product Code MUJ
Product Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only

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, elec- tron 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 Versions 13.X and 15.X
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		 There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water equivalent range incorrectly for non-square 3D CT images (either different number of pixels in X and Y, or non-square pixels). Before the dose is calculated, Eclipse resamples the CT images to create a calculation image with a maximum resolution of 256 x 256. The PCS algorithm assumes uniform resolution in X and Y directions, or that X = Y for all images, and erroneously sets the Y = X for dose calcu- lation. For images that are not square, where either X<>Y, or the length of X does not equal the length of Y, the computed water equivalent range R is erroneous compared to the correct range R: 1) X=Y; R =R (R is correct); 2) XY R >R (R is too big).
FDA Determined
Cause 2		 Software design
Action The firm, Varian, disseminated the "URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE" dated 12/17/2018 to its customers on 12/26/2018. The letter explained the product, problem and a work around. The customers were instructed to do the following: ¿ Please retain a copy of this document along with your most current product labeling. complete the attached Recall Return Response form provided. Kindly return the completed form to returnresponse@varian.com ¿ Advise the appropriate personnel working in your radiotherapy department of the content of this letter. ¿ For future reference, this document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. Varian Medical Systems has developed a technical correction for this issue. You will be contacted by a Customer Service representative to schedule its installation on your system. If you require further clarification, please feel free to contact your local Varian Medical Systems Customer Support District or Regional Manager or Varian Oncology Help Desk Contact Information at +1.888.827.4265 or Email: support @varian.com.
Quantity in Commerce 1450 devices
Distribution Worldwide distribution: US (nationwide) and countries of: Australia, Brazil, Denmark France, Germany, Japan, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Sweden, Switzerland, Taiwan, and United Kingdom.
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 = MUJ and Original Applicant = Varian Medical Systems, Inc.
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