Recall Z-2219-2010 ยท MUJ System, Planning, Radiation Therapy Treatment
TomoTherapy Incorporated
Hi-Art System, H-0000-0003 Usage: The TomoTherapy Hi-Art System is 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. The megavoltage x-ray radiation is delivered in a rotational, non-r
| Date | Aug 12, 2010 (initiated Dec 1, 2009) |
| Status | Terminated |
| Reason | An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs allow for images to be moved during planning. During registration when roll is applied on moved images, the Operator Station incorrectly rolls the image about |
| Root cause | Software design |
| Action | Consignee was sent a TomoTherapy "Urgent Medical device Correction Field Safety Notice' dated December 01, 2009. The letter described the Issue, Product Affected, Recommended Action and Resolution. |
| Quantity | 1 |
| Distribution | VA |
| 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 |