Reported Aug 27, 2014 · Terminated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2…
TomoTherapy Incorporated
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: TomoTherapy Incorporated · 1240 Deming Way · Madison, WI · 53717-1954
Is this the product you have?
- TomoTherapy Treatment System
- ModelHi-Art
- Catalog/Part Number
H-0000-0003software versions 1.2.01.2.1 and 1.2.2 (Hi-Art¿ 4.2.04.2.1 and 4.2.2)
- Lot codes and dates
- Serial #
320 of 320 codes
110403110366110319110352110034110083110140110336110126110009110129110014110332110333110212110287110130110417110133110450110416110365110389110340110341110372110279110370110345110167110292110061110142110334110306110342110143110351110374110208110356110430110315110447110431110444110124110263110123110151110294110435110111110422110353110364110384110261110297110157
- Serial #
- Amount recalled
- 322
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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