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Terminated

HiArt versions 4.0.x, and HD versions 1.0.x, H-0000-0003. 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.

FDA Recall Z-3108-2011 · Posted 2011-08-31

Recalling FirmAccuray Incorporated
Recall StatusTerminated
Product CodeMUJ
Date Initiated2011-07-13
Date Terminated2014-03-18
Product Quantity346

Reason for Recall

As a result of an internal review, TomoTherapy has identified an issue with HiArt versions 4.0.x, and HD versions 1.0.x that we would like to bring to your attention. During DICOM export of plan level images with a non square exported Field of View (FOV), an anomaly in the process of squaring the plan level image may cause the image to shift with respect to ROIs and dose. When the anomaly occu

Firm Action

TomoTherapy sent a "Urgent Medical Device Correction" letter dated July 13, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. This issue will be remedied with HiArt software version 4.1 and HD software version 1.1 and later. If you have any questions, please contact the TomoTherapy Technical Solutions Center by e-mail "[email protected]" . Please refer to the letter for what phone number you should call depending on where you are.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution-- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI and WY and the countries United Arab Emirates United Kingdom Turkey Switzerland Sweden Spain Saudi Arabia Poland Netherlands Italy Germany France Belgium Taiwan Singapore Malaysia Korea Japan India Hong Kong China Australia Mexico El Salvador and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082005MODIFICATION TO HI-ART TREATMENT SYSTEMTomotherapy Incorporated · 2008-08-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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