FDAFDA · Food and drugs·Recall number Z-2462-2012

Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA 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, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes.

Published October 3, 2012 · Recall initiated: August 17, 2012

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Varian Medical Systems, Inc. Oncology Systems
Distributor: Worldwide Distribution - USA (nationwide) and Internationally. . .
Lot: CP-08922: LIST OF SERIAL NUMBERS: H480001, H480130, H480301, H480446, H480623, H480795, H480976, H481088, H481222, H481382, H481544, H481777, H481931, H480002, H480131, H480302, H480448, H480624, H480798, H480981, H481089, H481229, H481383, H481545, H481778, H481932, H480008, H480132, H480305, H480449, H480627, H480808, H480982, H481090, H481230, H481389, H481556, H481787, H481935, H480009, H480133, H480312 ,H480450 ,H480628 ,H480814 ,H480989 ,H481099 ,H481231 ,H481392 ,H481562 ,H481793 ,H481938 ,H480010 ,H480137 ,H480313 ,H480451 ,H480629 ,H480819 ,H480992 ,H481100 ,H481232 ,H481393 ,H481581 ,H481795 ,H481939 ,H480011 ,H480138 ,H480314 ,H480455 ,H480630 ,H480820 ,H480993 ,H481104 ,H481233 ,H481394 ,H481582 ,H481796 ,H481940 ,H480012 ,H480139 ,H480315 ,H480464 ,H480631 ,H480821 ,H480994 ,H481105 ,H481234 ,H481397 ,H481590 ,H481798 ,H481945 ,H480013 ,H480151 ,H480316 ,H480465 ,H480645 ,H480822 ,H480996 ,H481108 ,H481235 ,H481404 ,H481591 ,H481799 ,H481946 ,H480014 ,H480153 ,H480319 ,H480467 ,H480652 ,H480823 ,H480997 ,H481109 ,H481236 ,H481409 ,H481592 ,H481803 ,H481953 ,H480015 ,H480157 ,H480320 ,H480468 ,H480659 ,H480824 ,H480998 ,H481110 ,H481237 ,H481410 ,H481602 ,H481805 ,H482120 ,H480016 ,H480158 ,H480321 ,H480469 ,H480660 ,H480825 ,H481003 ,H481111 ,H481239 ,H481414 ,H481603 ,H481806 ,H482121 ,H480017 ,H480159 ,H480323 ,H480471 ,H480665 ,H480839 ,H481004 ,H481112 ,H481256 ,H481415 ,H481606 ,H481807 ,H482125 ,H480019 ,H480160 ,H480324 ,H480477 ,H480667 ,H480840 ,H481010 ,H481115 ,H481257 ,H481416 ,H481609 ,H481815 ,H482126 ,H480020 ,H480169 ,H480325 ,H480478 ,H480668 ,H480841 ,H481012 ,H481122 ,H481277 ,H481417 ,H481613 ,H481818 ,H482129 ,H480030 ,H480170 ,H480333 ,H480486 ,H480670 ,H480842 ,H481014 ,H481132 ,H481278 ,H481418 ,H481614 ,H481821 ,H482130 ,H480031 ,H480172 ,H480338 ,H480487 ,H480673 ,H480843 ,H481015 ,H481133 ,H481279 ,H481420 ,H481616 ,H481835 ,H482131 ,H480032 ,H480173 ,H480340 ,H480493 ,H480674 ,H480844 ,H481016 ,H481135 ,H481289 ,H481423 ,H481617 ,H481836 ,H482132 ,H480033 ,H480174 ,H480341 ,H480494 ,H480676 ,H480845 ,H481022 ,H481136 ,H481290 ,H481424 ,H481618 ,H481837 ,H482133 ,H480034 ,H480175 ,H480342 ,H480495 ,H480677 ,H480846 ,H481023 ,H481139 ,H481291 ,H481428 ,H481619 ,H481838 ,H482134 ,H480040 ,H480177 ,H480345 ,H480502 ,H480678 ,H480847 ,H481024 ,H481142 ,H481292 ,H481432 ,H481620 ,H481848 ,H482135 ,H480043 ,H480178 ,H480346 ,H480505 ,H480679 ,H480849 ,H481025 ,H481143 ,H481293 ,H481433 ,H481622 ,H481849 ,H482136 ,H480051 ,H480184 ,H480350 ,H480507 ,H480685 ,H480850 ,H481026 ,H481144 ,H481294 ,H481443 ,H481635 ,H481850 ,H482137 ,H480052 ,H480185 ,H480351 ,H480508 ,H480686 ,H480855 ,H481027 ,H481146 ,H481296 ,H481445 ,H481636 ,H481851 ,H482138 ,H480053 ,H480207 ,H480358 ,H480514 ,H480687 ,H480856 ,H481028 ,H481147 ,H481298 ,H481451 ,H481638 ,H481852 ,H482144 ,H480054 ,H480208 ,H480359 ,H480521 ,H480688 ,H480865 ,H481029 ,H481149 ,H481299 ,H481452 ,H481639 ,H481853 ,H482162 ,H480055 ,H480209 ,H480360 ,H480522 ,H480691 ,H480866 ,H481030 ,H481150 ,H481304 ,H481453 ,H481641 ,H481858 ,H482163 ,H480063 ,H480210 ,H480361 ,H480523 ,H480702 ,H480868 ,H481031 ,H481151 ,H481306 ,H481454 ,H481647 ,H481862 ,H482164 ,H480064 ,H480215 ,H480362 ,H480524 ,H480712 ,H480873 ,H481032 ,H481154 ,H481307 ,H481455 ,H481648 ,H481863 ,H482166 ,H480065 ,H480216 ,H480365 ,H480526 ,H480714 ,H480874 ,H481036 ,H481155 ,H481309 ,H481456 ,H481649 ,H481865 ,H482167 ,H480067 ,H480217 ,H480371 ,H480527 ,H480715 ,H480878 ,H481037 ,H481157 ,H481311 ,H481467 ,H481650 ,H481866 ,H482168 ,H480072 ,H480218 ,H480372 ,H480528 ,H480717 ,H480879 ,H481039 ,H481158 ,H481312 ,H481471 ,H481651 ,H481867 ,H482172 ,H480075 ,H480233 ,H480378 ,H480530 ,H480719 ,H480886 ,H481043 ,H481159 ,H481313 ,H481472 ,H481667 ,H481870 ,H482174 ,H480076 ,H480239 ,H480379 ,H480531 ,H480722 ,H480890 ,H481045 ,H481163 ,H481315 ,H481477 ,H481671 ,H481871 ,H482178 ,H480078 ,H480240 ,H480388 ,H480539 ,H480723 ,H480894 ,H481046 ,H481164
Risk classification: Class II
Area (FDA): device
Country: United States

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