Cl Il TomoTherapy Hi-Art System

Company: TomoTherapy Inc.
Date of Enforcement Report 9/3/2008
Class:ll

PRODUCT
TomoTherapy Hi-Art System with software versions 3.0 and 3.1 – Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy, Recall # Z-1615-2008

REASON
In certain cases of HI-ART Systems operating with 3.0 or 3.1 SW, the registration adjustment field numbers may appear as nonsense characters or values on printed pages of the Register Tab. These values may appear differently than those shown on the Operator Station (OS) display. For example, the number “8” may appear as the number “0” on the printed page. During the registration process, the HI-ART couch will achieve the accepted and approved registered position automatically. However, if the operator subsequently adjusts the couch position manually based on a printout with the anomaly, the patient may be in the incorrect position during treatment.

RECALLING FIRM/MANUFACTURER
Tomo Therapy Inc., Madison, WI, by letter dated February 22, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
32 systems

DISTRIBUTION
Nationwide and Internationallytp>

About the author

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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