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

Recall Z-2041-2012 — Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; 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 malignan

U.S. FDA — Device Enforcement · United States · 2012-06-18 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2041-2012
Date of alert: 2012-06-18
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Varian Medical Systems, Inc. Oncology Systems
Product category: device
Product type: Devices

Reported risk: Varian has identified an anomaly with the Eclipse Treatment Planning (for radiotherapy treatments) where changing the prescription in a calculated VMAT or RapidArc plan may lead to Monitor Units which do not reflect the new prescription. If the dose prescription of a VMAT or RapidArc plan is changed after the initial Dose Volume Optimization, the Monitor Units and dose distribution may not reflect

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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