Recall Z-0814-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
TomoTherapy Incorporated
ThomoTherapy Hi-Art System Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue.
| Date | Dec 27, 2010 (initiated Nov 8, 2010) |
| Status | Terminated |
| Reason | TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure. |
| Root cause | Software design |
| Action | Consignees were sent a TomoTherapy "Urgent Field Safety Notice" dated November 8, 2010. The letter addressed to TomoTherapy Customers described the Issue, Product Affected, Recommended Action and Resolution. Customers are to contact the TomoTherapy Customer Interaction Center for further instruction and assistance in generating a completion procedure, if they experience the issue. Questions should be directed towards the TomoTherapy Customer Interaction Center via email or telephone. |
| Quantity | 40 (21US; 19 OUS) |
| Distribution | Worldwide Distribution -- USA, including the states of AZ, CO, IL, KS, MI, MO, NV, NY, ND, OH, OK PA, UT, and VA and countries of MALAYSIA, SWITZERLAND, KOREA, ITALY, SPAIN, CANDA, TAIWAN, JAPAN, BELGIUM |
| 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 |