Company: TomoTherapy, Inc
Date of Enforcement Report 1/28/2009
Class:ll
PRODUCT
TomoTherapy HI-ART Systems with versions 2.2.4, 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. TomoTherapy HI-ART Systems is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital health tissue. The HI-Art system’s planning station or operator station is intended to be used by the physician/oncologists to prescribe a radiation therapy plan for a particular patient,. The HI-ART System then calculates the treatment plan which the physician reviews and approves. The HI-ART system’s operator station and status console is then intended to be used by the therapist to select and implement the patient’s treatment plan. The treatment process will begin by performing a TomoImage (MVCT) scan (a CT using the on board linear accelerator as the radiation source). This TomoImage (MVCT) will confirm that the patient’s position is correct for the radiation therapy as well as assist in patient re-positioning when necessary. The TomoImage (MVCT) image is not for diagnostic use. When patient positioning is complete, the HI-ART System i sthen intended to be used by the therapist to treat the patient using the selected treatment plan. The HI-ART System delivers the radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment in accordance with the physician approved plan delivered in a helical tomographic pattern. Recall # Z-0628-2009
REASON
A potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the “Superuser” and “Field Service engineer” categories. Other security level users, including “Therapist”, cannot modify these settings. In the calibration panel, it is possible for “Superuser” and “Field Service Engineer” user types to manually disable the front and back jaw potentiometer interlock. This interlock is always correctly enabled prior to factory shipment of systems from TomoTherapy, and there are no service procedure that requires the interlock to be disabled. If this setting were to be manually disabled, the jaw would not perform a verification of the pre-procedure homing routine. In the unlikely event that this verification routine failed in a rare and very specific manner, the jaws could position incorrectly for that procedure without a system interlock occurring. This positioning error could only result in a field width that is smaller than planned. Fractions that would be affected would only be those incurring the unusual chain of events outlined above. Regardless, overdose in not a possible outcome.
RECALLING FIRM/MANUFACTURER
TomoTherapy, Inc., Madison, WI, by letter dated October 17, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
215 units
DISTRIBUTION
Nationwide and Internationally
