Reported Oct 3, 2012 · Terminated
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier:…
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?
3 of 3 products
| Model / number | Product as published |
|---|---|
H48 | Varian brand Eclipse Treatment Planning System |
| — | Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922 |
| — | 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 algorithim is specifically indicated for planning proton treatment of neoplasms of the eyes. |
- Lot codes and dates
- CP-08922LIST
- OF SERIAL NUMBERS
3,585 of 3,585 codes
H480001H480130H480301H480446H480623H480795H480976H481088H481222H481382H481544H481777H481931H480002H480131H480302H480448H480624H480798H480981H481089H481229H481383H481545H481778H481932H480008H480132H480305H480449H480627H480808H480982H481090H481230H481389H481556H481787H481935H480009H480133H480312H480450H480628H480814H480989H481099H481231H481392H481562H481793H481938H480010H480137H480313H480451H480629H480819H480992H481100
- Amount recalled
- 6087
Where it was sold
- Nationwide
Why it was recalled
Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation when the clock on the Eclipse Client Workstation is not synchronized with the Database/System Server. Treatment of the patient using these values can therefore lead to under or over-dose.
This product could cause temporary or reversible health problems — stop using it.
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