Recall Z-2041-2012— Varian Medical Systems, Inc. Oncology Systems

Class II FDA medical device recall by Varian Medical Systems, Inc. Oncology Systems, initiated 2012-06-18, terminated 2014-08-06. FDA's recall record names no specific 510(k) clearance for this event. Product: 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 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. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.. Reason: 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.

Recalling firm

Varian Medical Systems, Inc. Oncology Systems

Classification

Class II

Status

Terminated

Initiated

2012-06-18

Terminated

2014-08-06

Firm location

Palo Alto, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.