TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Medical device recall Z-0507-2015. Published in FDA’s Enforcement Report on Dec 17, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 17, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 27 states named
- 210 ( 72 USA; 138 OUS ) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
210 ( 72 USA; 138 OUS ), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SN 110441 110403 110485 110055 110394 110126 110266 110511 110332 110333 110499 110468 110508 110470 110505 110507 110522 110385 110388 110228 110334 110494 110480 110109 110462 110471 110501 110469 110356 110478 110260 110275 110457…
Every code shown here, 1,472 characters
SN 110441 110403 110485 110055 110394 110126 110266 110511 110332 110333 110499 110468 110508 110470 110505 110507 110522 110385 110388 110228 110334 110494 110480 110109 110462 110471 110501 110469 110356 110478 110260 110275 110457 110430 110315 110447 110314 110506 110170 110465 110510 110496 110472 110077 110347 110124 110259 110117 110294 110146 110419 110189 110446 110422 110467 110353 110364 110384 110410 110363 110300 110162 110267 110428 110405 110299 110246 110429 110071 110232 110200 110305 110330 110407 110361 110136 110413 110458 110231 110371 110211 110304 110479 110409 110466 110437 110164 110205 110392 110487 110489 110184 110397 110036 110451 110427 110426 110327 110475 110454 110093 110476 110400 110377 110484 110455 110453 110486 110393 110498 110085 110229 110412 110425 110434 110459 110088 110386 110301 110448 110481 110328 110504 110068 110078 110474 110482 110491 110464 110387 110137 110290 110308 110285 110445 110497 110503 110206 110463 110038 110502 110060 110500 110106 110180 110013 110081 110033 110490 110420 110368 110492 110402 110115 110040 110210 110509 110438 110415 110050 110396 110424 110097 110202 110349 110203 110408 110090 110244 110456 110084 110027 110029 110473 110209 110091 110281 110286 110094 110155 110381 110100 110271 110390 110493 110174 110483 110452 110268 110360 110176 110516 110269 110367 110227 110369 110323 110461 110254 110395 110383 110348 110515 110477 110488 110021 110196 110298 110158 110495
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
27 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Florida
- Georgia
- Illinois
- Indiana
- Kansas
- Maryland
- Minnesota
- Missouri
- North Carolina
- Nebraska
- New Mexico
- New York
- Oklahoma
- Oregon
- Pennsylvania
- South Dakota
- Tennessee
- Texas
- Utah
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 21, 2014.
- FDA classified it on Dec 5, 2014.
- FDA’s Enforcement Report published it on Dec 17, 2014.
- FDA terminated it on Jul 17, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- TomoTherapy Incorporated, of Madison, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.