Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0990-2017 — 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

U.S. FDA — Device Enforcement · United States · 2016-12-02 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0990-2017
Date of alert: 2016-12-02
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Varian Medical Systems, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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