Varian Medical Systems, Inc.: 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.

Recall number

Z-0771-2019

Recalling firm

Varian Medical Systems, Inc.

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.

Status

Terminated

Initiated

2018-12-26

Posted

not on file

Terminated

2021-03-10

Reason

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).

Root cause

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

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.

Lot, serial or model codes

Versions 13.X and 15.X

510(k) numbers

["K170969","K172163","K181145"]

PMA numbers

not on file

Product code

MUJ

Firm FEI

2916710

Firm city

Palo Alto

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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