FDA Device recall Z-2462-2012

Varian brand Eclipse Treatment Planning System, Model Number: H48

FDA Device
Class II
terminated
Published 2012-10-03

On 2012-10-03 the FDA classified a Class II recall of Varian brand Eclipse Treatment Planning System, Model Number: H48 by Varian Medical Systems Oncology Systems, citing varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the E….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2462-2012
Classification	Class II
Status	terminated
Initiated	2012-08-17
Published	2012-10-03
Last updated	2026-09-13 11:53 UTC
Company	Varian Medical Systems Oncology Systems
Distribution	US

Product

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.

Reason

Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the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.

Identifiers

code_info	CP-08922: LIST OF SERIAL NUMBERS: H480001, H480130, H480301, H480446, H480623, H480795, H480976, H481088, H481222,… 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 ,H48

code_info

CP-08922: LIST OF SERIAL NUMBERS: H480001, H480130, H480301, H480446, H480623, H480795, H480976, H481088, H481222,…

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 ,H48

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-2462-2012%22

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