Recall – Image resampling algorithm error

Company: Varian Medical Systems, Inc.
Date of Enforcement Report: 1/24/2019
Class II

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.

Recall Number: Z-0771-2019

REASON

There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algorithm 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 calculation. 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)

RECALLING FIRM/MANUFACTURER

Varian Medical Systems, Inc., Palo Alto, CA on 12/26/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1450 devices

DISTRIBUTION
U.S. Nationwide and International

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