Recall Z-0771-2019 ยท MUJ System, Planning, Radiation Therapy Treatment
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.
| Date | Dec 26, 2018 |
| Status | Terminated |
| 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 |
| 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 docum |
| 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. |
| FDA record | Open on fda.gov |