Recall Z-3163-2011 ยท MUJ System, Planning, Radiation Therapy Treatment
Accuray Incorporated
TomoMobile, Hi-Art System, H-0000-0003, TomoTherapy 1240 Deming Way, Madison, WI 53717 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 megavoltag
| Date | Jul 7, 2011 |
| 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 TomoMobile Hi-Art System. TomoTherapy has discovered that when attempting to open the TomoMobile shielding doors, while the door hinges are in the locked position, the hinges may fail allowing the door to disengage from the shielding. |
| Root cause | Device Design |
| Action | The firm, TomoTherapy, sent an "Urgent Medical Device Correction" letter dated July 7, 2011 to its consignees/customers. The letter described the Issue, Product Affected, Recommended Action (advised consignees to not attempt to open the shielding doors when the hinges are in the locked position. The Hinges should always be in the unlocked position when opening the doors) and Resolution. A TomoTherapy field service engineer or an authorized service representative will contact the customers when a resolution is available. If you have any questions, please contact the TomoTherapy Technical S |
| Quantity | 4 |
| Distribution | Worldwide distribution: USA including states of: AZ, CA and OK; and country of: United Arab Emirates |
| 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 |