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Tomotherapy Incorporated

United StatesFDA applicant, unverified

Devices
6
FDA recalls
12

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

Catalogue6

Newest first, rows 1-6 of 6

FDA recalls12

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Showing the 10 most recent of 12 recalls.

  • 2014

    • 21 Nov 2014 Z-0507-2015 Class II Terminated Accuray has become aware of a potential safety issue related to the TomoTherapy Treatment System caused by a failure to monitor the jaw position after a jaw error occurs. This may result in an incorrect jaw position during treatment, without generating system interruption. Distribution: Worldwide Distribution - USA (nationwide) included the states of : AL, AZ, AR, CA, FL, GA, IL, IN, KS, ,Y, MD, MN, MO,…
      Full distribution text Worldwide Distribution - USA (nationwide) included the states of : AL, AZ, AR, CA, FL, GA, IL, IN, KS, ,Y, MD, MN, MO, NE, NM, NY, NC, OK, OR, PA, SD, TN, TX, UT, WA, WV, WI and WY., and the countries of : JAPAN, BELGIUM, NETHERLANDS, ITALY, GERMANY, KOREA, FRANCE, SWITZERLAND, ENGLAND, CANADA, MEXICO, HONG KONG, AUSTRALIA, SRI LANKA, GREECE, CHINA, PHILIPPINES, MARTINIQUE, ROMANIA, SPAIN and TURKEY.
      Submission number: K121934
    • 17 Jul 2014 Z-2239-2014 Class II Terminated Accuray is voluntarily recalling TomoTherapy H Series software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art 4.2.0, 4.2.1 and 4.2.2). Accuray has identified potential safety issues (anomalies) with these software versions. Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of US:; AL, AK, AZ, CA, CO, CT, FL,…
      Full distribution text Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of US:; AL, AK, AZ, CA, CO, CT, FL, GA, HI, IL IN, IA, KS,KY, LA, MD, MA, MI, MO, MT, NE, NV, NJ, NM, NY, NC,ND, OH,OK, OR, PA, SC, SD, TX, UT, VA, WV, and WI, and the countries of AUSTRALIA, BELGIUM CANDA, CHINA, EL SALVADOR, ENGLAND, FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, NETHERLANDS, PHILIPPINE, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.
      Submission number: K121934
    • 16 Jul 2014 Z-2240-2014 Class II Terminated Accuray is voluntarily recalling TomoTherapy H Series software versions 2.0.0 and 2.0.1 (Hi-Art 5.0.0 and 5.0.1). Accuray has identified potential safety issues (anomalies) with these software versions. Distribution: Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK,…
      Full distribution text Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of AUSTRALIA, BELGIUM, CANADA, CHINA, ENGLAND, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, PHILIPPINES, RUSSIA, SPAIN, TAIWAN, TURKEY, MARTINIQUE, ROMANIA, SRI LANKA and SWITZERLAND.
      Submission number: K121934

  • 2011

    • 26 Jan 2011 Z-1649-2011 Unclassified (pre-2012) Terminated It was determined that the Treatment Planning Station (TPS) can potentially under dose. Distribution: Worldwide Distribution -- US, including States of: AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL, IN, IA, KS, KY, LA,…
      Full distribution text 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.
      Submission number: K082005

  • 2010

    • 8 Nov 2010 Z-0814-2011 Unclassified (pre-2012) Terminated TomoTherapy Inc. is sending this Field Safety Notice to make you aware of an anomaly which may affect the performance of the Hi-Art System and make it so the user cannot generate a Completion Procedure. Distribution: Worldwide Distribution -- USA, including the states of AZ, CO, IL, KS, MI, MO, NV, NY, ND, OH, OK PA, UT, and VA and…
      Full distribution text Worldwide Distribution -- USA, including the states of AZ, CO, IL, KS, MI, MO, NV, NY, ND, OH, OK PA, UT, and VA and countries of MALAYSIA, SWITZERLAND, KOREA, ITALY, SPAIN, CANDA, TAIWAN, JAPAN, BELGIUM
      Submission number: K082005
    • 23 Jun 2010 Z-2072-2010 Unclassified (pre-2012) Terminated An issue has been identified, as a result of input received from one TomoTherapy Hi-Art Treatment System customer. With a particular workflow, the Planning Station's Draft and/or final Plan Report can provide incorrect dose statistics. Distribution: CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN,…
      Full distribution text CA, CO, IL, LA, MI, MO, NY, ND, OH, OK, PA,VA, WI, BELGIUM CANADA, KOREA, MALAYSIA, SWITZERLAND, ITALY, GREAT BRITAIN, FRANCE.
      Submission number: K082005
    • 22 Feb 2010 Z-2115-2010 Unclassified (pre-2012) Terminated In some cases, the patient's diagnostic CT image is narrower than the Hi-Art radiotherapy couch image. Distribution: Worldwide Distribution -- MI, MO, VA, and WI and country of CANADA. Submission number: K082005

  • 2009

    • 1 Dec 2009 Z-2219-2010 Unclassified (pre-2012) Terminated An issue was identified with the TomoTherapy HI-Art System. In the event a patient or DQA plan has a moved image, roll adjustments applied during registration will be incorrect. The Planning Station Plan Settings and DQA Setup tabs allow for images to be moved during planning. During registration when roll is applied on moved images, the Operator Station incorrectly rolls the image about Distribution: VA Submission number: K082005
    • 10 Aug 2009 Z-2243-2009 Unclassified (pre-2012) Terminated TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station (OS) did not display the dose rate and the procedure time, or the couch position updates. Within a few minutes, the customer pressed the Stop button on the Sta Distribution: Worldwide Distribution -- US (states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI,…
      Full distribution text Worldwide Distribution -- US (states of AL, AK, AZ, AR, CA, CO, CT, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN,MO, NE,NV,NJ, NM, NY, OH, OK OR, PA, PR, SC, SC, TN, TX, UT, VA, WA, WI and WY) and Belgium Canada Switzerland China Germany Spain France England Hong Kong India Italy Japan Korea Netherlands Poland Saudi Arabia Sweden Singapore Turkey and Taiwan.
      Submission number: K060912

  • 2008

    • 14 Oct 2008 Z-0628-2009 Unclassified (pre-2012) Terminated TomoTherapy Incorporated identified a potential issue with the Hi-Art system during the course of ongoing testing. The Operator Station Calibration panel provides access to view and modify machine specific configuration settings. Access to these settings has always been restricted to individuals with appropriate security rights, being limited to only the "Superuser" and "Field Service engine Distribution: Worldwide Distribution --- USA including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA,…
      Full distribution text Worldwide Distribution --- USA including states of AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NV, NJ, NM, NY, OH,OK , OR, PR, PA, SC, SD, TN, TX, VA, WA, WI, WY, and DC, and countries of BELGIUM, CANADA, SWITZERLAND, CHINA, GERMANY, SPAIN, FRANCE, GREAT BRITAIN, HONG KONG, ITALY, JAPAN, KOREA, NETHERLANDS, SINGAPORE, TAIWAN and TURKEY.
      Submission number: K060912
Show all 12 recalls

  • 2008

    • 18 Sep 2008 Z-0339-2009 Unclassified (pre-2012) Terminated TomoTherapy Inc. discovered an issue on the Hi-Art system during the course of ongoing testing. It has been identified that treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the DVH curve and the Dose Statistics for the small structures. This error can only happen if planning was performed using very small voxels Distribution: AK AL AR AZ CA CO CT DC FL HI IA IL IN KY LA MA MD MI MN MO NE NJ NM NV NY OH OK OR PA PR SC SD TN TX VA WA WI and WY…
      Full distribution text AK AL AR AZ CA CO CT DC FL HI IA IL IN KY LA MA MD MI MN MO NE NJ NM NV NY OH OK OR PA PR SC SD TN TX VA WA WI and WY Belgium Canada Switzerland Germany Spain France Great Britain India Italy Japan Korea Netherlands Turkey and Taiwan
      Submission number: K060912
    • 22 Feb 2008 Z-1615-2008 Unclassified (pre-2012) Terminated 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…
      Full distribution text 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.
      Submission number: K060912

Frequently asked questions

How many devices does Tomotherapy Incorporated have in the registry?

The registry currently lists 6 devices for Tomotherapy Incorporated. Devices recorded under merged duplicate company entries are counted once.

Which registries list Tomotherapy Incorporated's devices?

Among its 6 most recently registered devices, Tomotherapy Incorporated has devices listed in FDA 510(k) (6 devices).

What risk classes do Tomotherapy Incorporated's devices fall under?

Among its 6 most recently registered devices, the classes recorded for Tomotherapy Incorporated's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Tomotherapy Incorporated?

FDA recall records list 12 recalls initiated by Tomotherapy Incorporated, the most recent initiated on 21 Nov 2014. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Tomotherapy Incorporated in the registry?

The most recently registered devices listed for Tomotherapy Incorporated include TOMOTHERAPY TREATMENT SYSTEM FAST OPTIMIZER, MODIFICATION TO: HI-ART SYSTEM, MODIFICATION TO HI-ART TREATMENT SYSTEM and HI-ART SYSTEM.

Generated automatically from registry data and not verified by a human reviewer.