Reported Aug 27, 2014 · Terminated
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1…
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 NumberH-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physicians prescribed and approved plan
- Lot codes and dates
- Serial #
168 of 168 codes
110013110021110025110027110028110029110033110037110038110050110053110055110060110065110077110078110081110082110084110088110090110095110096110100110102110106110109110117110121110131110137110146110147110155110158110162110163110164110169110170110174110180110189110196110197110202110205110226110227110228110231110232110248110254110259110260110264110266110268110270
- Serial #
- Amount recalled
- 168 (75 US; 93 OUS)
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 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions.
This product could cause temporary or reversible health problems — stop using it.
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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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