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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 4 of 4 Results
510(K) Number: K060912
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Product Description
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Recall
Class
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FDA Recall
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Recalling Firm
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TomoTherapy Hi-Art System®, Version 3.X ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 5371... 2 09/21/2009 TomoTherapy Incorporated
TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applica... 2 01/22/2009 TomoTherapy Incorporated
TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Pl... 2 01/05/2009 TomoTherapy Incorporated
TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The devic... 2 08/24/2008 TomoTherapy Incorporated
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