TomoTherapy 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.
FDA Recall Z-0339-2009 · Posted 2009-01-05
Recalling FirmTomoTherapy Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-09-18
Date Terminated2011-04-19
Product Quantity165
Reason for Recall
TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that 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. This error can only happen if planning was performed using very small voxels
Firm Action
Consignees were sent on 9/18/08 a "TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice" letter dated September 17, 2008. The letter described the issue, product affected, recommended actions and resolution. Questions may be directed to TomoTherapy Inc. Customer Service Center at 1-868-368-4807.
Root Cause
Software design
Distribution Pattern
AK AL AR AZ CA CO CT DC FL HI IA IL IN KY LA MA MD MI MN MO NE NJ NM NV NY OH OK OR PA PR SC SD TN TX VA WA WI and WY Belgium Canada Switzerland Germany Spain France Great Britain India Italy Japan Korea Netherlands Turkey and Taiwan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.