Recall Z-2072-2010 ยท MUJ System, Planning, Radiation Therapy Treatment
TomoTherapy Incorporated
TomoTherapy Hi-Art System, ver. 4.0.0, 4.0.1, 4.0.2, ThomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. The TomoTherapy HI-ART System 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 r
| Date | Jul 22, 2010 (initiated Jun 23, 2010) |
| Status | Terminated |
| Reason | An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect dose statistics. |
| Root cause | Software design |
| Action | Consignees were sent on 6/23/10 a TomoTherapy "Urgent Field Safety Notice Medical device Correction" letter dated June 22, 1010. The letter addressed the Issue, Product Affected, Recommended Action and Resolution. Prior to generating a draft or final Plan Report for a given plan, the plan must be closed and reopened at least once. This issue will be remedied by Hi-Art software version 4.0.3, scheduled for release in late 2010. Customers with questions were provided with a contact in the letter at the TomoTherapy Customer Interaction Center. The firm can be contacted at 608-824-2800. |
| Quantity | 29 |
| Distribution | CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082005 | MODIFICATION TO HI-ART TREATMENT SYSTEM Tomotherapy Incorporated, Aug 25, 2008 |