FDA Device recall Z-2041-2012

Varian brand Varian Eclipse Treatment Planning System for radiotherapy

FDA Device
Class II
terminated
Published 2012-07-25

On 2012-07-25 the FDA classified a Class II recall of Varian brand Varian Eclipse Treatment Planning System for radiotherapy by Varian Medical Systems Oncology Systems, citing 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 t….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2041-2012
Classification	Class II
Status	terminated
Initiated	2012-06-18
Published	2012-07-25
Last updated	2026-09-13 11:53 UTC
Company	Varian Medical Systems Oncology Systems
Distribution	US

Product

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.

Reason

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

Identifiers

code_info	Affected Devices: H480110 ,H486186 ,H48B178 ,H48D026 ,H48D966 ,H487806 ,H48B764 ,H48B218 ,H48C503 ,H488467 ,H481815… 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

code_info

Affected Devices: H480110 ,H486186 ,H48B178 ,H48D026 ,H48D966 ,H487806 ,H48B764 ,H48B218 ,H48C503 ,H488467 ,H481815…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2041-2012%22

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