Reported Jul 25, 2012 · Terminated
Varian brand Varian Eclipse Treatment Planning System for radiotherapy; Model Number: H48; Product is manufactured and…
Varian Medical Systems, Inc. Oncology Systems
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. Oncology Systems · 911 Hansen Way · Palo Alto, CA · 94304-1028
Is this the product you have?
- Varian brand Varian Eclipse Treatment Planning System for radiotherapy
- Model NumberH48; 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
- Lot codes and dates
- Affected Devices
3,586 of 3,586 codes
H480110H486186H48B178H48D026H48D966H487806H48B764H48B218H48C503H488467H481815H48D923H48E486H480267H486446H48B179H48D027H48A565H487807H48B765H48B963H48B756H488468H481816H48E896H48B426H480268H486447H48B180H48D028H48A566H487808H482178H48B964H48B757H489917H485467H48E897H48B668H480269H487164H48B181H48D029H48D566H487809H489962H48B965H482450H48A912H48A254H489213H48B669H480270H487165H48B182H48D030H488558H487810H489963H48B966
- Affected Devices
- Amount recalled
- 7113 units
Where it was sold
- Nationwide
- PR
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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