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Terminated

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.

FDA Recall Z-1615-2008 · Posted 2008-08-24

Recalling FirmTomoTherapy Incorporated
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-02-22
Date Terminated2008-12-02
Product Quantity32

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.

Firm 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

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060912MODIFICATION TO: HI-ART SYSTEMTomotherapy Incorporated · 2006-04-19

Official Source

View FDA Recall →

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

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