FDA Device recall Z-2240-2014
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1)
- FDA Device
- Class II
- terminated
- Published 2014-08-27
On 2014-08-27 the FDA classified a Class II recall of TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1) by Tomotherapy, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2240-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-16 |
| Published | 2014-08-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tomotherapy |
| Distribution | US |
Product
TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). The TomoTherapy treatment system is intended to be used as an integrated system for the 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/three dimensional conformal) format in accordance with the physicians prescribed and approved plan.
Reason
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.
Identifiers
| code_info | Serial # 110013 110021 110025 110027 110028 110029 110033 110037 110038 110050 110053 110055 110060 11006…Serial # 110013 110021 110025 110027 110028 110029 110033 110037 110038 110050 110053 110055 110060 110065 110077 110078 110081 110082 110084 110088 110090 110095 110096 110100 110102 110106 110109 110117 110121 110131 110137 110146 110147 110155 110158 110162 110163 110164 110169 110170 110174 110180 110189 110196 110197 110202 110205 110226 110227 110228 110231 110232 110248 110254 110259 110260 110264 110266 110268 110270 110275 110285 110286 110290 110298 110308 110314 110327 110328 110338 110347 110348 110349 110352 110355 110360 110363 110367 110368 110369 110373 110377 110381 110383 110385 110386 110387 110388 110392 110394 110395 110396 110397 110402 110408 110409 110410 110411 110413 110415 110419 110420 110424 110427 110434 110438 110441 110445 110446 110448 110451 110452 110453 110454 110455 110456 110457 110458 110459 110460 110461 110462 110463 110464 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2240-2014%22
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