Events

Device Recall HiArt(R) System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Accuray Incorporated 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    78686
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0286-2018
  • 사례 시작날짜
    2017-11-17
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160115
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Accelerator, linear, medical - Product Code IYE
  • 원인
    Uncontrolled couch z-axis movement (descent).
  • 조치
    Accuray sent an Urgent Field Safety Notice letter dated November 8, 2017, to affected customers. The letter identified the affected product, problem and actions to be taken. The letter stated the following: "Accuray(R) will correct all affected High-Performance Patient Couches. An Accuray representative will contact you to arrange a time to update your system. The update includes the installation of TomoTherapy(R)' H(TM) Series software version 2.1.2 (Hi ¿Art(R) vS.1.2) on your system, as well as the replacement of cables within the couch subsystem." For questions contact Accuray Customer Support by phoning the regional support lines.

Device

Device Recall HiArt(R) System
  • 모델명 / 제조번호(시리얼번호)
    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
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution
  • 제품 설명
    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.
  • Manufacturer
    Accuray Incorporated

Manufacturer

Accuray Incorporated
  • 제조사 주소
    Accuray Incorporated, 1240 Deming Way, Madison WI 53717-1954
  • 제조사 모회사 (2017)
    Accuray Inc
  • Source
    USFDA