Reported Dec 17, 2014 · Terminated
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
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 with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
- Lot codes and dates
- SN
210 of 210 codes
110441110403110485110055110394110126110266110511110332110333110499110468110508110470110505110507110522110385110388110228110334110494110480110109110462110471110501110469110356110478110260110275110457110430110315110447110314110506110170110465110510110496110472110077110347110124110259110117110294110146110419110189110446110422110467110353110364110384110410110363
- SN
- Amount recalled
- 210 ( 72 USA; 138 OUS )
Where it was sold
Why it was recalled
Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption.
This product could cause temporary or reversible health problems — stop using it.
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