Recall Z-1649-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
TomoTherapy Incorporated
TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.
| Date | Mar 14, 2011 (initiated Jan 26, 2011) |
| Status | Terminated |
| Reason | It was determined that the Treatment Planning Station (TPS) can potentially under dose. |
| Root cause | Software design |
| Action | Consignees were sent a TomoTherapy "Field Safety Notice Medical Device Correction" letter dated January 26, 2011. The letter was addressed to "TomoTherapy Customer". The letter described the Planning Issue, Related DQA Consideration, Graphical Presentation of Results, Product Affected, Recommended Action and Resolution. The letter suggests to use the information presented in order to avoid creating plans with an increased potential for discrepancies in planned vs. delivered dose. Specifically include measurements for small, off-axis targets that could be susceptible to the effects of this |
| Quantity | 326 |
| Distribution | Worldwide Distribution -- US, including States of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NJ, NM, NY ,NC, ND,OH, OK OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of SPAIN, GERMANY, FRANCE, INDIA, KOREA, SWEDEN, ITALY, M |
| 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 |