Hi-Art(R) System
Medical device recall Z-0286-2018. Published in FDA’s Enforcement Report on Jan 3, 2018.
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 Jan 3, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 250 units 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?
Uncontrolled couch Z-axis movement (descent)
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissues. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non- modulated (non-IMRT/3 dimensional conformal) format in accordance with the physicians prescribed and approved plan.
250 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 110016 110022 110024 110029 110030 110036 110038 110045 110046 110050 110054 110055 110056 110058 110060 110061 110065 110066 110067 110069 110071 110073 110077 110078 110084 110085 110087 110088 110090 110091 110092 110094…
Every code shown here, 1,765 characters
Serial Numbers: 110016 110022 110024 110029 110030 110036 110038 110045 110046 110050 110054 110055 110056 110058 110060 110061 110065 110066 110067 110069 110071 110073 110077 110078 110084 110085 110087 110088 110090 110091 110092 110094 110097 110098 110099 110103 110104 110106 110109 110110 110112 110113 110114 110115 110116 110117 110120 110122 110124 110125 110126 110127 110128 110133 110136 110141 110142 110144 110146 110148 110150 110151 110152 110153 110154 110156 110157 110159 110161 110164 110165 110166 110167 110168 110170 110171 110172 110174 110175 110176 110177 110181 110183 110184 110189 110190 110191 110192 110193 110196 110198 110200 110202 110203 110204 110205 110207 110209 110210 110211 110212 110213 110215 110216 110217 110218 110220 110222 110223 110224 110225 110227 110229 110232 110233 110234 110235 110236 110238 110239 110240 110241 110244 110245 110246 110247 110249 110251 110252 110253 110254 110255 110256 110257 110258 110259 110260 110261 110262 110263 110267 110269 110271 110272 110273 110275 110276 110278 110279 110281 110282 110283 110284 110285 110287 110288 110291 110292 110293 110294 110295 110296 110297 110298 110299 110301 110303 110304 110305 110306 110307 110308 110310 110312 110313 110314 110316 110317 110319 110320 110321 110323 110324 110325 110326 110327 110328 110329 110330 110331 110334 110335 110337 110339 110340 110341 110342 110343 110344 110345 110346 110349 110351 110356 110358 110359 110361 110362 110365 110366 110367 110370 110371 110372 110374 110375 110377 110382 110383 110389 110393 110395 110400 110403 110404 110416 110421 110423 110428 110429 110432 110433 110435 110438 110439 110440 110443 110449 110450 110456 110459 110468 110497 110499 110505 110507 110508 110509 110510 110522
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
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 17, 2017.
- FDA classified it on Dec 26, 2017.
- FDA’s Enforcement Report published it on Jan 3, 2018.
- FDA terminated it on Jul 25, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Accuray 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
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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.