FDA Device recall Z-2239-2014
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…
- 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 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2… by Tomotherapy, citing 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 (an….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2239-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-07-17 |
| 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 1.2.0, 1.2.1 and 1.2.2 (Hi-Art¿ 4.2.0, 4.2.1 and 4.2.2). .
Reason
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.
Identifiers
| code_info | Serial # 110403 110366 110319 110352 110034 110083 110140 110336 110126 110009 110129 110014 110332 11033…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 |
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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-2239-2014%22
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