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>