Reported Jan 13, 2021 · Terminated
TomoTherapy Treatment Delivery System with iDMS - Product Usage: used as an integrated system for the planning and…
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?
- TomoTherapy Treatment Delivery
- System with iDMS - Product Usageused 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 tissue
- Lot codes and dates
- Product Codes
1044301018286H-0000-00031018283
- System Version1.2 (also referred to as 5.6.2)
- Serial Numbers
110105110219110221110267110284110290110308110368
- Product Codes
- Amount recalled
- 8 units
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
"MLC tickle error" may result in the delivered dose to effectively rotate from the planned dose.
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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