Recall Z-0628-2009 ยท IYE Accelerator, Linear, Medical
TomoTherapy Incorporated
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
| Date | Jan 22, 2009 (initiated Oct 14, 2008) |
| Status | Terminated |
| Reason | TomoTherapy Incorporated identified 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 engine |
| Root cause | Software design |
| Action | A TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated October 17, 2008 was sent to all consignees. The letter addressed the Issue, Product Affected, Recommended Actions and Resolution. Please direct questions to the TomoTherapy, Inc. Customer Care Center by email (www.support@tomotherapy.com) or by telephone, North America: 1-866-368- 4807 and all other locations: 1-608-824-2900 or 32-2-400-44-44. |
| Quantity | 215 |
| Distribution | Worldwide Distribution --- USA including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NM, NY, OH,OK , OR, PR, PA, SC, SD, TN, TX, VA, WA, WI, WY, and DC, and countries of BELGIUM, CANADA, SWITZERLAND, CHINA, GERMANY, SPAIN, FRANCE, GREAT BRITA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060912 | MODIFICATION TO: HI-ART SYSTEM Tomotherapy Incorporated, Apr 19, 2006 |