CLASS II Device recall · Reported 18 Jan 2017 · FDA Enforcement Report

Eclipse Treatment Planning System recalled by Varian Medical Systems

Varian Medical Systems is recalling Eclipse Treatment Planning System, distributed in Florida, New Jersey, Tennessee. The recall was initiated on 2 Dec 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel # H48 Serial numbers: H48L574 H48L575 H48L576 H48L577 H48L578 H48L579 H48L580 H48L581 H48L582 H48L583 H48L584 H48L585 H48L586 H48L587 H482484 H487302 H48A587 H48D957 H480113 H480118 H481884 H481885 H481886 H481916 H481917 H484198 H484199 H488949 H48A680 H48A871 H48A872 H48A873 H48A874 H48A875 H48A876 H48A877 H48A878 H48A879 H48I531 H481195 H481236 H481237.

Quantity recalled42 devices are affected

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0990-2017
FDA event ID: 76018
Recalling firm: Varian Medical Systems, Palo Alto, CA
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2016
FDA classified: 10 Jan 2017
Reported: 18 Jan 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

2 Dec 2016	Recall initiated by company
10 Jan 2017	Classified by FDA	+39 days
18 Jan 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Modifications in version 13.6MR2 for Contouring, SmartAdapt, and SmartSegmentation workspaces resulted in contours not being saved consistently in Eclipse. Treatment Planning System. The issue only occurs if certain conditions are fulfilled.

Product as listed by the FDA

Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: 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.

Where it was distributed

US Distribution to the states of : NJ, TN. OR and FL.

Florida New Jersey Tennessee

Questions about this recall

Is Eclipse Treatment Planning System recalled?

Yes. Varian Medical Systems recalled Eclipse Treatment Planning System on 2 Dec 2016. The recall is Class II and its status is Terminated. Recall number Z-0990-2017.

Why was it recalled?

Which lots are affected?

Model # H48 Serial numbers: H48L574 H48L575 H48L576 H48L577 H48L578 H48L579 H48L580 H48L581 H48L582 H48L583 H48L584 H48L585 H48L586 H48L587 H482484 H487302 H48A587 H48D957 H480113 H480118 H481884 H481885 H481886 H481916 H481917 H484198 H484199 H488949 H48A680 H48A871 H48A872 H48A873 H48A874 H48A875 H48A876 H48A877 H48A878 H48A879 H48I531 H481195 H481236 H481237.

Where was it sold?

US Distribution to the states of : NJ, TN. OR and FL.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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