Z-0771-2019Class II

Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The...

Name: Z-0771-2019 Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The...
Creator: Varian Medical Systems, Inc.
Published: 2018-12-26
License: https://open.fda.gov/license/

Varian Medical Systems, Inc. / initiated 2018-12-26 / Terminated / root cause: software

FDA source

Varian Medical Systems, Inc. began a recall of Eclipse(TM) Treatment Planning System with Proton Convolution Superposition algorithm license only The Eclipse Treatment Planning System (Eclipse TPS) is used... on 2018-12-26. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0771-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-26
Posted: 2019-01-24
Terminated: 2021-03-10
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.
Product code: MUJ System, Planning, Radiation Therapy Treatment
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).
Root cause tag: software
FDA 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 [email protected] 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.
Product codes and lots: Versions 13.X and 15.X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0771-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0771-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24

Product code MUJ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)