Recall Z-2115-2010 ยท MUJ System, Planning, Radiation Therapy Treatment
TomoTherapy Incorporated
TomoTherapy Hi-Art System, Version 4.0.0 & 4.0.1. TomoTherapy Incorporated 1240 Deming Way, Madison, WI 53717. Intended to be used as an integrated system for 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 | Aug 2, 2010 (initiated Feb 22, 2010) |
| Status | Terminated |
| Reason | In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image. |
| Root cause | Software design |
| Action | Consignees were sent on 2/22/10 a TomoTherapy Incorporated "Urgent Medical Device Correction Field Safety Notice" letter dated Monday, February 22, 2010. The letter was addressed to TomoTherapy Customer and identified the the affected product, and included a description of the Issue, Product Affected, Recommendation Actions and Resolution. The issue will be remedied by software versions 4.0.2 and later. Questions should be directed towards TomoTherapy Customer Interaction Center by e-mail or telephone. |
| Quantity | 7 |
| Distribution | Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA. |
| 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 |