Reported Jan 3, 2018 · Terminated
TomoHDA(R) System, Model Number 1018286 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?
- TomoHDA(R) System
- Model Number 1018286 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
87 of 87 codes
110033110137110155110206110221110290110318110348110353110360110364110384110408110410110411110452110457110463110473110475110476110477110478110479110481110483110484110485110486110487110488110489110490110492110493110496110498110500110502110513110514110515110516110518110520110521110523110524110526110529110530110535110538110542110543110550110551110557110559110560
- Serial Numbers
- Amount recalled
- 87 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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