# FDA recall Z-0771-2019

> **Varian Medical Systems, Inc.** · Class II · device recall initiated 2018-12-26.

## 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.

## 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) X<Y: R <R (R  is too small) and 3) X>Y  R >R (R  is too big).

## 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.

## Key facts

- **Recall number:** Z-0771-2019
- **Recalling firm:** Varian Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-12-26
- **Report date:** 2019-01-30
- **Termination date:** 2021-03-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Palo Alto, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0771-2019

## Citation

> AI Analytics. FDA recall Z-0771-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0771-2019. Source: US FDA. Licensed CC0.

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