FDAFDA · Food and drugs·Recall number Z-2041-2012

Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; 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 algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.

Published July 25, 2012 · Recall initiated: June 18, 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 (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Varian Medical Systems, Inc. Oncology Systems
Distributor: Worldwide distribution: USA (nationwide) and countries including of: Austria, Australia, Bahrain, Belgium, Brazil, Canada, China, Chile, Colombia, Denmark, Egypt, Finland, France,Germany, Greece, Hungary, Hong Kong, India, Indonesia, Israel, Ireland, Italy, Japan, Latvia, Malaysia, Mexico, Morocco, Nepal, Netherlands, Norway, Panama, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, United Kingdom, Taiwan, Turkey, Ukraine, United Arab Emirates and Venezuela.
Lot: Affected Devices: H480110 ,H486186 ,H48B178 ,H48D026 ,H48D966 ,H487806 ,H48B764 ,H48B218 ,H48C503 ,H488467 ,H481815 ,H48D923 ,H48E486 ,H480267 ,H486446 ,H48B179 ,H48D027 ,H48A565 ,H487807 ,H48B765 ,H48B963 ,H48B756 ,H488468 ,H481816 ,H48E896 ,H48B426 ,H480268 ,H486447 ,H48B180 ,H48D028 ,H48A566 ,H487808 ,H482178 ,H48B964 ,H48B757 ,H489917 ,H485467 ,H48E897 ,H48B668 ,H480269 ,H487164 ,H48B181 ,H48D029 ,H48D566 ,H487809 ,H489962 ,H48B965 ,H482450 ,H48A912 ,H48A254 ,H489213 ,H48B669 ,H480270 ,H487165 ,H48B182 ,H48D030 ,H488558 ,H487810 ,H489963 ,H48B966 ,H482451 ,H48A913 ,H48C429 ,H489214 ,H48B670 ,H480271 ,H487166 ,H48B183 ,H48D031 ,H488559 ,H48D203 ,H48C022 ,H48C177 ,H482452 ,H48A914 ,H48B523 ,H489215 ,H48B671 ,H480272 ,H487167 ,H48B184 ,H48D032 ,H488560 ,H48D204 ,H48E169 ,H48C178 ,H483272 ,H48A915 ,H48B524 ,H484763 ,H48B672 ,H482174 ,H487168 ,H48B185 ,H48D033 ,H488561 ,H48D361 ,H48E170 ,H48C179 ,H484360 ,H48A916 ,H48B525 ,H484764 ,H48B673 ,H482934 ,H487169 ,H48B186 ,H481109 ,H489079 ,H48D362 ,H48E171 ,H485020 ,H488594 ,H48A917 ,H48B526 ,H484765 ,H48B674 ,H484123 ,H487170 ,H480953 ,H481110 ,H489110 ,H48D363 ,H48E172 ,H485021 ,H488595 ,H48C365 ,H48B527 ,H484766 ,H48B675 ,H485462 ,H487171 ,H480954 ,H481111 ,H48A614 ,H48D364 ,H48E493 ,H486023 ,H48A940 ,H48C366 ,H48B528 ,H485112 ,H48B676 ,H485590 ,H487172 ,H483209 ,H481323 ,H48A542 ,H48D365 ,H48E494 ,H488361 ,H48C141 ,H48E610 ,H489244 ,H486821 ,H48B677 ,H486422 ,H487173 ,H489760 ,H481671 ,H48D329 ,H48D366 ,H48E495 ,H488362 ,H48C142 ,H48E615 ,H489245 ,H489516 ,H48B678 ,H486423 ,H487974 ,H48E523 ,H481672 ,H48D330 ,H48D367 ,H489683 ,H488363 ,H48C143 ,H48E616 ,H489246 ,H489517 ,H48B679 ,H486424 ,H487975 ,H48E568 ,H481673 ,H48E385 ,H48D368 ,H489526 ,H488364 ,H48C144 ,H485992 ,H48A109 ,H489518 ,H48B680 ,H486425 ,H487976 ,H48E590 ,H481674 ,H481154 ,H480567 ,H489527 ,H48A703 ,H48C146 ,H485994 ,H48D432 ,H489519 ,H48B681 ,H486426 ,H48B150 ,H48E591 ,H481675 ,H481155 ,H480568 ,H489530 ,H48A704 ,H48C147 ,H485995 ,H48E389 ,H48C203 ,H48B682 ,H486427 ,H48B302 ,H48E592 ,H481676 ,H481156 ,H480569 ,H489531 ,H48A705 ,H489130 ,H485996 ,H482311 ,H48A274 ,H48B683 ,H486428 ,H48C019 ,H48E593 ,H484853 ,H483874 ,H480594 ,H48A253 ,H48A706 ,H489131 ,H48A952 ,H482312 ,H48A275 ,H48B684 ,H486429 ,H48C045 ,H480167 ,H484854 ,H489232 ,H480595 ,H48E088 ,H48A707 ,H489132 ,H48A953 ,H482313 ,H48A276 ,H48B685 ,H48B995 ,H48C046 ,H480168 ,H485093 ,H485656 ,H485633 ,H48E089 ,H48A708 ,H489133 ,H48A954 ,H482314 ,H48A277 ,H48B686 ,H48B996 ,H486633 ,H480285 ,H485094 ,H485657 ,H485634 ,H48E090 ,H48A709 ,H485678 ,H48A955 ,H482315 ,H48A278 ,H48B687 ,H481912 ,H486634 ,H481021 ,H485095 ,H485677 ,H485635 ,H48E091 ,H48D393 ,H485679 ,H48A960 ,H482316 ,H48B785 ,H48B688 ,H481913 ,H486635 ,H481608 ,H485096 ,H487661 ,H485636 ,H48E092 ,H48E317 ,H489094 ,H48A961 ,H482317 ,H48D894 ,H48B689 ,H481914 ,H486636 ,H482439 ,H485952 ,H487662 ,H485637 ,H48E093 ,H48E318 ,H48C294 ,H48A962 ,H482318 ,H48D895 ,H48B690 ,H481915 ,H486637 ,H483845 ,H485988 ,H487663 ,H485638 ,H48E094 ,H48E319 ,H48C295 ,H48A972 ,H482319 ,H48D896 ,H480732 ,H484396 ,H48C776 ,H48C412 ,H487126 ,H48B076 ,H485639 ,H48E095 ,H481927 ,H48C296 ,H48C290 ,H482320 ,H481309 ,H480748 ,H48D548 ,H483756 ,H48C413 ,H487127 ,H48B077 ,H485640 ,H48E096 ,H481928 ,H48E138 ,H48C291 ,H482321 ,H481310 ,H487708 ,H48D549 ,H488991 ,H48C414 ,H487128 ,H48D487 ,H485641 ,H489363 ,H481929 ,H48E140 ,H48C292 ,H482322 ,H482287 ,H487709 ,H48D550 ,H488675 ,H48C415 ,H487129 ,H48D488 ,H486017 ,H489364 ,H481930 ,H48E144 ,H48C293 ,H484876 ,H483517 ,H489558 ,H48D551 ,H48C047 ,H48C416 ,H487640 ,H480329 ,H48D340 ,H489365 ,H481931 ,H48E146 ,H48B194 ,H484877 ,H484398 ,H489559 ,H481551 ,H48C048 ,H486509 ,H487641 ,H480339 ,H48D341 ,H489366 ,H489856 ,H48E336 ,H48B195 ,H484878 ,H486308 ,H48A941 ,H482656 ,H48C049 ,H48D983 ,H487642 ,H480960 ,H48D342 ,H489418 ,H489857 ,H48E337 ,H48C975 ,H484879 ,H486311 ,H480378 ,H482657 ,H48E524 ,H481215 ,H48B153 ,H481640 ,H48D347 ,H488582 ,H489858 ,H48E338 ,H48
Risk classification: Class II
Area (FDA): device
Country: United States

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