Company: ThomoTherapy Inc.
Date of Enforcement Report 1/14/2009
Class:ll
PRODUCT
ThomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy, Recall # Z-0339-2009
REASON
Treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the DVH curve and the Dose Statistics for the small structures. The error can result in up to 30% inaccuracy in the DVH curve and Dose Statistics.
RECALLING FIRM/MANUFACTURER
TomoTherapy, Inc., Madison, WI, by letter dated September 17, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
165 units
DISTRIBUTION
Nationwide, Belgium, Canada, Switzerland, Germany, Spain, France, Great Britain, India, Italy, Japan, Korea, Netherlands, Turkey, and Taiwan
