Recall Z-0339-2009 ยท IYE Accelerator, Linear, Medical
TomoTherapy Incorporated
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.
| Date | Jan 5, 2009 (initiated Sep 18, 2008) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Software design |
| 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. |
| Quantity | 165 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060912 | MODIFICATION TO: HI-ART SYSTEM Tomotherapy Incorporated, Apr 19, 2006 |