TomoTherapy Treatment System with software versions 2.0.1 /… recallZ-0507-2015 · TomoTherapy Incorporated · initiated Nov 21, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from TomoTherapy Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
Accuray sent an "Urgent Field Safety Notice" dated November 21, 2014, to all affected customers. The letter identified the problem the product and the action needed to be taken by the customers. For questions they can contact Accuray Customer Support at 1-877-668-8667 or visit the Accuray Technical Solutions Center at www.accuray.com>Services & Support or call: North America: +1.877.668.8667, Europe: +800.4141.9595, Hong Kong: +852.2247.8688, Japan: +81.3.6269.9556. Requested consignees to complete and return the Acknowledgement Form to Accuray Regulatory Affairs.
Recall details
- Recall number
- Z-0507-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 21, 2014
- Posted by the FDA
- Dec 12, 2014
- Recalling firm
- TomoTherapy Incorporated
- Quantity
- 210 ( 72 USA; 138 OUS )
- Product code
- IYE
- FDA submissions
- K121934
- Distribution
- 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.
Product description
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)
Code information (models, lots, serial numbers)
Show the full code information (1k 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
Other devices under the same FDA submission
1 device cleared under K121934 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TomoTherapy Treatment System (Tomo HD™) H-0000-0003Accuray Incorporated · Accelerator, Linear, Medical6 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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