Reported Jan 18, 2017 · Terminated
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version…
Varian Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Varian Medical Systems, Inc. · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12]
- RadiologyThe 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
- Lot codes and dates
- Model #
- H48 Serial numbers
H48L574H48L575H48L576H48L577H48L578H48L579H48L580H48L581H48L582H48L583H48L584H48L585H48L586H48L587H482484H487302H48A587H48D957H480113H480118H481884H481885H481886H481916H481917H484198H484199H488949H48A680H48A871H48A872H48A873H48A874H48A875H48A876H48A877H48A878H48A879H48I531H481195H481236H481237
- Amount recalled
- 42 devices are affected
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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