Jan

2009

Cl Il ThomoTherapy HI-ART Systems

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Cl Il ThomoTherapy HI-ART Systems

Amy Sellers

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