Recall Z-2243-2009 ยท MUJ System, Planning, Radiation Therapy Treatment
TomoTherapy Incorporated
TomoTherapy Hi-Art System, Version 3.X 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 radiation to vi
| Date | Sep 21, 2009 (initiated Aug 10, 2009) |
| Status | Terminated |
| Reason | TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station (OS) did not display the dose rate and the procedure time, or the couch position updates. Within a few minutes, the customer pressed the Stop button on the Sta |
| Root cause | Software design |
| Action | Consignees were sent a TomoTherapy "Urgent Medical Device Correction Field Safety Notice" letter dated August 10, 2009. The letter addressed the Issue, Product Affected, Investigation, Recommended Actions and Resolution. Customers were recommended to perform the following actions (in the event that the dose rate, procedure timer, and couch position updates are not present on the OS, after pressing Start on the status console and the radiation on light and audible indicators are active): 1) Immediately press the Stop button on the Status Console and 2) contact your authorized TomoTherapy Servi |
| Quantity | 259 (169 US; 91 OUS) |
| Distribution | Worldwide Distribution -- US (states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN,MO, NE,NV,NJ, NM, NY, OH, OK OR, PA, PR, SC, SC, TN, TX, UT, VA, WA, WI and WY) and Belgium Canada Switzerland China Germany Spain France England Hong Kong India Italy Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060912 | MODIFICATION TO: HI-ART SYSTEM Tomotherapy Incorporated, Apr 19, 2006 |