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Medical Device Recalls
Class 2 Recall
TomoTherapy Hi-Art System
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Date Recall Initiated |
February 22, 2008
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Date Posted |
August 24, 2008
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Recall Number |
Z-1615-2008
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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.
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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
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Recalling Firm/ Manufacturer |
TomoTherapy Incorporated
1240 Deming Way
Madison
, Wisconsin
53717-1954
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Reason For Recall |
In certain cases of HI-ART Systems operating with 3.0 or 3.1 SW, the registration adjustment field numbers may appear as nonsense characters or values on printed pages of the Register Tab. These values may appear differently than those shown on the Operator Station (OS) display. For example, the number "8" may appear as the number "0" on the printed page.
During the registration process, the H
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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.
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Quantity in Commerce |
32
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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.
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