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-rotational, modulated (IMRT), or non modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan
This recall has been terminated (originally issued August 12, 2010).
- Company
- Tomotherapy Incorporated
- Recall Initiated
- December 1, 2009
- Posted
- August 12, 2010
- Terminated
- December 17, 2011
- Recall Number
- Z-2219-2010
- Quantity
- 1
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
Reason for Recall
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
Distribution
VA
Lot / Code Info
110019
Root Cause
Software design
Action Taken
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.
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