medical Class II Updated 2017-01-18

Varian Medical Systems, Inc. recalls Eclipse Treatment Planning System version 13.MR2 [13.06.31

Recalled Product

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.

Hazard / Issue

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.

Issued by

FDA

Affected States: NJ, TN, OR, FL
Lot/Code Info: 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.
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