Events

Device Recall TomoTherapy Treatment System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 TomoTherapy 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
    68948
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2239-2014
  • 사례 시작날짜
    2014-07-17
  • 사례 출판 날짜
    2014-08-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-09-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129092
  • 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
    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.
  • 조치
    Consignees were sent an Accuray "Urgent Device Correction" letter dated July 16, 2014. The letter was addressed to TomoTherapy System Medical Physicist. The letter described the Purpose of this letter, Description of the Potential Problems, Safety Instructions and software upgrade information. For questions or concerns they can contact Accuray Customer Support at 1-877-668-8667 (USA) or 1-408-716-4700(non-USA) or customersupport@accuray.com

Device

Device Recall TomoTherapy Treatment System
  • 모델명 / 제조번호(시리얼번호)
    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 110236 110153 110181 110439 110411 110241 110295 110064 110303 110249 110058 110114 110296 110414 110110 110240 110313 110079 110191 110156 110128 110069 110362 110310 110207 110423 110443 110433 110382 110421 110375 110460 110335 110404 110307 110324 110325 110432 110321 110245 110440 110194 110317 110418 110051 110177 110108 110206 110120 110257 110329 110179 110311 110125 110115 110040 110074 110406 110283 110165 110195 110225 110161 110210 110160 110204 110175 110006 110098 110144 110187 110217 110262 110214 110067 110047 110222 110097 110119 110048 110149 110221 110198 110193 110239 110203 110318 110215 110258 110244 110256 110312 110023 110378 110132 110201 110016 110322 110343 110145 110282 110190 110039 110026 110250 110056 110216 110066 110320 110401 110035 110209 110091 110281 110346 110380 110379 110284 110099 110094 110273 110105 110054 110168 110186 110185 110122 110272 110331 110234 110020 110243 110059 110271 110390 110188 110041 110251 110224 110116 110255 110252 110042 110238 110247 110309 110134 110135 110073 110101 110024 110218 110219 110045 110316 110220 110154 110138 110152 110087 110276 110176 110092 110057 110086 110269 110166 110213 110127 110005 110030 110003 110139 110323 110022 110104 110399 110339 110354 110344 110112 110118 110141 110223 110192 110044 110121 110226 110270 110338 110274 110046 110358 110253 110103 110235
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of US:; AL, AK, AZ, CA, CO, CT, FL, GA, HI, IL IN, IA, KS,KY, LA, MD, MA, MI, MO, MT, NE, NV, NJ, NM, NY, NC,ND, OH,OK, OR, PA, SC, SD, TX, UT, VA, WV, and WI, and the countries of AUSTRALIA, BELGIUM CANDA, CHINA, EL SALVADOR, ENGLAND, FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, NETHERLANDS, PHILIPPINE, POLAND, RUSSIA, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY, and UNITED ARAB EMIRATES.
  • 제품 설명
    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). || .
  • Manufacturer
    TomoTherapy Incorporated

Manufacturer

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