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Terminated

TomoTherapy Hi-ART System, Model # H-0000-0003 Intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or sterotactic radiosurgery to tumors or the targeted tissues.

FDA Recall Z-1649-2011 · Posted 2011-03-14

Recalling FirmTomoTherapy Incorporated
Recall StatusTerminated
Product CodeMUJ
Date Initiated2011-01-26
Date Terminated2014-03-18
Product Quantity326

Reason for Recall

It was determined that the Treatment Planning Station (TPS) can potentially under dose.

Firm Action

Consignees were sent a TomoTherapy "Field Safety Notice Medical Device Correction" letter dated January 26, 2011. The letter was addressed to "TomoTherapy Customer". The letter described the Planning Issue, Related DQA Consideration, Graphical Presentation of Results, Product Affected, Recommended Action and Resolution. The letter suggests to use the information presented in order to avoid creating plans with an increased potential for discrepancies in planned vs. delivered dose. Specifically include measurements for small, off-axis targets that could be susceptible to the effects of this issue. DQA dose measurements should be performed at each unique full fraction dose that will be used for patient treatment, without using DQA scaling. If Customers have any questions they are to contact TomoTherapy Interaction Center by email or phone.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- US, including 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, NV, NJ, NM, NY ,NC, ND,OH, OK OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of SPAIN, GERMANY, FRANCE, INDIA, KOREA, SWEDEN, ITALY, MALAYSIA, SWITZERLAND, CANADA, UNITED KINGDOM, SINGAPORE, TURKEY, TAIWAN, AUSTRALIA, JAPAN, BELGIUM, CHINA, MEXICO, NETHERLANDS, POLAND, SAUDI ARABIA, and UNITED ARAB EMIRATES.

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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