FDA Device recall Z-0805-2016

Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6

FDA Device
Class II
terminated
Published 2016-02-24

On 2016-02-24 the FDA classified a Class II recall of Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6 by Varian Medical Systems, citing when using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not co….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0805-2016
Classification	Class II
Status	terminated
Initiated	2016-01-11
Published	2016-02-24
Last updated	2026-09-13 11:54 UTC
Company	Varian Medical Systems
Distribution	US

Product

Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: 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.

Reason

When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.

Identifiers

code_info	Model: H48: Serial numbers: H480110 H48C045 H488552 H480119 H487642 H480345 H480409 H480541 H480814 H48D577 H4812… Model: H48: Serial numbers: H480110 H48C045 H488552 H480119 H487642 H480345 H480409 H480541 H480814 H48D577 H481205 H48D125 H48I971 H488466 H48A830 H48G592 H48L819 H480267 H48C046 H488553 H480123 H48B153 H480348 H489828 H480542 H480819 H48D580 H481206 H48D126 H48I972 H489917 H48K547 H48G593 H48L823 H480268 H48K563 H48I901 H480124 H48B154 H480349 H48E077 H480566 H480820 H48I607 H481262 H48E255 H48I973 H48A912 H481952 H486308 H48J014 H482174 H48L882 H48I790 H480126 H48F494 H480350 H487078 H480590 H480821 H480981 H485005 H48F454 H481213 H48A913 H48C377 H486311 H48J017 H482934 H487080 H48I793 H480132 H48F495 H480357 H48D491 H480591 H480849 H480982 H485006 H48F864 H48L831 H48A914 H48C381 H48A679 H48J019 H484123 H487081 H48J346 H480133 H48F496 H480362 H480410 H480596 H480850 H48G047 H48F796 H48F974 H48L833 H48A915 H482311 H48K023 H481437 H486422 H487130 H48J354 H480137 H48F497 H480365 H480422 H480599 H480869 H481010 H484510 H48L347 H48H963 H48A916 H482312 H48K024 H481449 H4

code_info

Model: H48: Serial numbers: H480110 H48C045 H488552 H480119 H487642 H480345 H480409 H480541 H480814 H48D577 H4812…

Model: H48: Serial numbers: H480110 H48C045 H488552 H480119 H487642 H480345 H480409 H480541 H480814 H48D577 H481205 H48D125 H48I971 H488466 H48A830 H48G592 H48L819 H480267 H48C046 H488553 H480123 H48B153 H480348 H489828 H480542 H480819 H48D580 H481206 H48D126 H48I972 H489917 H48K547 H48G593 H48L823 H480268 H48K563 H48I901 H480124 H48B154 H480349 H48E077 H480566 H480820 H48I607 H481262 H48E255 H48I973 H48A912 H481952 H486308 H48J014 H482174 H48L882 H48I790 H480126 H48F494 H480350 H487078 H480590 H480821 H480981 H485005 H48F454 H481213 H48A913 H48C377 H486311 H48J017 H482934 H487080 H48I793 H480132 H48F495 H480357 H48D491 H480591 H480849 H480982 H485006 H48F864 H48L831 H48A914 H48C381 H48A679 H48J019 H484123 H487081 H48J346 H480133 H48F496 H480362 H480410 H480596 H480850 H48G047 H48F796 H48F974 H48L833 H48A915 H482311 H48K023 H481437 H486422 H487130 H48J354 H480137 H48F497 H480365 H480422 H480599 H480869 H481010 H484510 H48L347 H48H963 H48A916 H482312 H48K024 H481449 H4

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0805-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.