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.
This recall has been terminated (originally issued August 24, 2008).
- Company
- Tomotherapy Incorporated
- Recall Initiated
- February 22, 2008
- Posted
- August 24, 2008
- Terminated
- December 2, 2008
- Recall Number
- Z-1615-2008
- Quantity
- 32
- Firm Location
- Madison, WI
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
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
Root Cause
Software design
Action Taken
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