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Class 2 Device Recall TomoTherapy HiArt System |
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Date Initiated by Firm |
February 22, 2008 |
Date Posted |
August 24, 2008 |
Recall Status1 |
Terminated 3 on December 02, 2008 |
Recall Number |
Z-1615-2008 |
Recall Event ID |
46965 |
510(K)Number |
K060912
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Product Classification |
Medical Linear Accelerator - Product Code IYE
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Product |
TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy. |
Code Information |
10002 10003 10007 10016 10019 10021 10028 10037 10044 10048 10050 10051 10056 10094 10165 10166 10168 10169 10174 10185 10186 10187 10188 10189 10190 10191 10192 10193 10194 10195 10196 10198 |
Recalling Firm/ Manufacturer |
TomoTherapy Incorporated 1240 Deming Way Madison WI 53717-1954
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For Additional Information Contact |
608-824-2800
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Manufacturer Reason for Recall |
Registration adjustment field numbers may appear on printed pages of the Register Tab as nonsense characters or values different than the numbers shown on the Operator Station (OS) display. Setup will move the couch to the correct offset position. If the couch is manually adjusted to the incorrect value, the patient may not be the correct position during treatment.
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FDA Determined Cause 2 |
Software design |
Action |
Consignees were sent a letter "TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice" dated February 22,2008. The letter described the Issue, Product Affected, Cause, Recommended Customer Action and Resolution.
If you have not received this letter or have questions, contact the firm as outlined below:
North America: 1 866 368 4807
Belgium: 0800 38783
France: 0805 631 565
Germany: 0800 000 7541
Italy: 800 986 399
Netherlands: 0800 0201364
Spain: 800 300049
Switzerland: 0800 001927
United Kingdom: 0808 238 6035
China/CNC (Northern): 10 800 712 1701
China (Southern): 10 800 120 1701
Hong Kong: 800 967912
Japan: 0044 22 132374
Singapore: 800 1204 683
South Korea: 0079 81 4800 7204
All other locations: +1 608 824 2900 or +32 2 400 44 44 |
Quantity in Commerce |
32 |
Distribution |
Worldwide Distribution --- USA including states of CA ,CT, DC, FL, IL, LA, MD, MI, MO, NE, NJ, NY, SC, TN, VA, WI , and countries of Canada, Germany, Taiwan, and Turkey. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = TOMOTHERAPY INCORPORATED
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