FDA Device recall Z-0286-2018
Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system fo…
- FDA Device
- Class II
- terminated
- Published 2018-01-03
On 2018-01-03 the FDA classified a Class II recall of Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system fo… by Accuray, citing uncontrolled couch Z-axis movement (descent).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0286-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-11-17 |
| Published | 2018-01-03 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Accuray |
| Distribution | n/a |
Product
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.
Reason
Uncontrolled couch Z-axis movement (descent)
Identifiers
| code_info | Serial Numbers: 110016 110022 110024 110029 110030 110036 110038 110045 110046 110050 110054 110055 110056…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0286-2018%22
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