Varian recalls Eclipse Treatment Planning System with Proton Conv: incorrect water equivalent range calculations for non-square CT images may affect proton therapy treatment planning.
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) X<Y: R <R (R is too small) and 3) X>Y R >R (R is too big).
Varian is recalling its Eclipse Treatment Planning System with Proton Convolution Superposition algorithm license. This software error could lead to incorrect radiation dose calculations for non-square CT images, potentially affecting proton therapy treatments.
The algorithm incorrectly calculates the water equivalent range for non-square CT images, which can lead to inaccurate radiation dose calculations. This error may cause the treatment to deliver too little or too much radiation to the target area, potentially affecting treatment effectiveness and safety.
Patients receiving proton therapy treatments using this specific software license are most at risk. Healthcare providers using the Eclipse system with this algorithm may also be affected.
The recall affects Eclipse Treatment Planning System with Proton Convolution Superposition algorithm licenses for versions 13.X and 15.X. This software is used for planning proton therapy treatments.
Verify if your Eclipse Treatment Planning System has Proton Convolution Superposition algorithm license for versions 13.X or 15.X.
The recall is due to an anomaly in the Proton Convolution Superposition algorithm that incorrectly calculates the water equivalent range for non-square CT images, which could affect proton therapy treatment planning.
The software error may lead to inaccurate radiation dose calculations, potentially causing the treatment to deliver too little or too much radiation to the target area.
Check if your Eclipse Treatment Planning System has Proton Convolution Superposition algorithm license for versions 13.X or 15.X.
We’ve drafted a message you can send Varian to request your refund or repair — edit it as you like.
Subject: Recall Z-0771-2019 — Varian Varian Hello, I own a Varian that is covered by recall Z-0771-2019 from Varian. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
