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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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 110245 110246 110247 110249 110251 110252 110253 110254 110255 110256 110257 110258 110259 110260 110261 110262 110263 110267 110269 110271 110272 110273 110275 110276 110278 110279 110281 110282 110283 110284 110285 110287 110288 110291 110292 110293 110294 110295 110296 110297 110298 110299 110301 110303 110304 110305 110306 110307 110308 110310 110312 110313 110314 110316 110317 110319 110320 110321 110323 110324 110325 110326 110327 110328 110329 110330 110331 110334 110335 110337 110339 110340 110341 110342 110343 110344 110345 110346 110349 110351 110356 110358 110359 110361 110362 110365 110366 110367 110370 110371 110372 110374 110375 110377 110382 110383 110389 110393 110395 110400 110403 110404 110416 110421 110423 110428 110429 110432 110433 110435 110438 110439 110440 110443 110449 110450 110456 110459 110468 110497 110499 110505 110507 110508 110509 110510 110522
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Accuray Incorporated
- Reason for Recall:
- Uncontrolled couch Z-axis movement (descent)
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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 110245 110246 110247 110249 110251 110252 110253 110254 110255 110256 110257 110258 110259 110260 110261 110262 110263 110267 110269 110271 110272 110273 110275 110276 110278 110279 110281 110282 110283 110284 110285 110287 110288 110291 110292 110293 110294 110295 110296 110297 110298 110299 110301 110303 110304 110305 110306 110307 110308 110310 110312 110313 110314 110316 110317 110319 110320 110321 110323 110324 110325 110326 110327 110328 110329 110330 110331 110334 110335 110337 110339 110340 110341 110342 110343 110344 110345 110346 110349 110351 110356 110358 110359 110361 110362 110365 110366 110367 110370 110371 110372 110374 110375 110377 110382 110383 110389 110393 110395 110400 110403 110404 110416 110421 110423 110428 110429 110432 110433 110435 110438 110439 110440 110443 110449 110450 110456 110459 110468 110497 110499 110505 110507 110508 110509 110510 110522
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0286-2018
Related Recalls
Snap rings may become partially or completed detached from the shafts within the internal mechanism. Uncontrolled rotation may occur on the left and right roll axes when the rings are removed or damaged.
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
Accuray Incorporated
It is possible the upper roller bracket in the Radixact System gantry enclosure may not provide enough clearance for service personnel to use a jib crane for moving components while servicing the system, resulting in possible injury to the service personnel.
The set screws that connect the Standard Treatment Couch linkage arm to the roll motor can loosen over time allowing the couch to roll.