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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68948

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 17, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
TomoTherapy Incorporated

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .

Z-2239-2014
Recall number
Z-2239-2014
Initiated
July 17, 2014
Classification
Class II
Status
Terminated
Recalling firm
TomoTherapy Incorporated
Quantity
322

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
anomalies) with these software

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Serial # 110403 110366 110319 110352 110034 110083 110140 110336 110126 110009 110129 110014 110332 110333 110212 110287 110130 110417 110133 110450 110416 110365 110389 110340 110341 110372 110279 110370 110345 110167 110292 110061 110142 110334 110306 110342 110143 110351 110374 110208 110356 110430 110315 110447 110431 110444 110124 110263 110123 110151 110294 110435 110111 110422 110353 110364 110384 110261 110297 110157 110300 110267 110428 110405 110299 110246 110429 110071 110200 110171 110305 110330 110407 110359 110361 110136 110371 110211 110304 110075 110063 110437 110183 110199 110184 110337 110049 110172 110076 110036 110426 110107 110113 110326 110093 110400 110393 110085 110229 110412 110425 110052 110182 110391 110178 110159 110291 110302 110350 110265 110288 110237 110150 110289 110301 110449 110293 110278 110442 110436 110148 110068 110233 110376 110236 110153 110181 110439 110411 110241 110295 110064 110303 110249 110058 110114 110296 110414 110110 110240 110313 110079 110191 110156 110128 110069 110362 110310 110207 110423 110443 110433 110382 110421 110375 110460 110335 110404 110307 110324 110325 110432 110321 110245 110440 110194 110317 110418 110051 110177 110108 110206 110120 110257 110329 110179 110311 110125 110115 110040 110074 110406 110283 110165 110195 110225 110161 110210 110160 110204 110175 110006 110098 110144 110187 110217 110262 110214 110067 110047 110222 110097 110119 110048 110149 110221 110198 110193 110239 110203 110318 110215 110258 110244 110256 110312 110023 110378 110132 110201 110016 110322 110343 110145 110282 110190 110039 110026 110250 110056 110216 110066 110320 110401 110035 110209 110091 110281 110346 110380 110379 110284 110099 110094 110273 110105 110054 110168 110186 110185 110122 110272 110331 110234 110020 110243 110059 110271 110390 110188 110041 110251 110224 110116 110255 110252 110042 110238 110247 110309 110134 110135 110073 110101 110024 110218 110219 110045 110316 110220 110154 110138 110152 110087 110276 110176 110092 110057 110086 110269 110166 110213 110127 110005 110030 110003 110139 110323 110022 110104 110399 110339 110354 110344 110112 110118 110141 110223 110192 110044 110121 110226 110270 110338 110274 110046 110358 110253 110103 110235

Distribution pattern

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.