Reported Jan 3, 2018 · Terminated
Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an…
Accuray 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: Accuray Incorporated · 1240 Deming Way · Madison, WI · 53717-1954
Is this the product you have?
- Hi-Art(R) System
- Model Number H-000-0003 Product UsageThe TomoTherapy treatment system is intended to be used as an integrated system for t he 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/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan
- Lot codes and dates
- Serial Numbers
250 of 250 codes
110016110022110024110029110030110036110038110045110046110050110054110055110056110058110060110061110065110066110067110069110071110073110077110078110084110085110087110088110090110091110092110094110097110098110099110103110104110106110109110110110112110113110114110115110116110117110120110122110124110125110126110127110128110133110136110141110142110144110146110148
- Serial Numbers
- Amount recalled
- 250 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Uncontrolled couch Z-axis movement (descent)
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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