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
    68960
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2240-2014
  • 사례 시작날짜
    2014-07-16
  • 사례 출판 날짜
    2014-08-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129117
  • 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 2.0.0 and 2.0.1 (hi-art¿ 5.0.0 and 5.0.1). accuray has identified potential safety issues (anomalies) with these software versions.
  • 조치
    Accuray sent an "Urgent Device Correction" letter dated July 16, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. These anomalies will be corrected with a new software version. You will be contacted by Accuray Customer Support to schedule a software upgrade to your system. If you have any questions or concerns regarding this issue, please do not hesitate to 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 # 110013 110021 110025 110027 110028 110029 110033 110037 110038 110050 110053 110055 110060 110065 110077 110078 110081 110082 110084 110088 110090 110095 110096 110100 110102 110106 110109 110117 110121 110131 110137 110146 110147 110155 110158 110162 110163 110164 110169 110170 110174 110180 110189 110196 110197 110202 110205 110226 110227 110228 110231 110232 110248 110254 110259 110260 110264 110266 110268 110270 110275 110285 110286 110290 110298 110308 110314 110327 110328 110338 110347 110348 110349 110352 110355 110360 110363 110367 110368 110369 110373 110377 110381 110383 110385 110386 110387 110388 110392 110394 110395 110396 110397 110402 110408 110409 110410 110411 110413 110415 110419 110420 110424 110427 110434 110438 110441 110445 110446 110448 110451 110452 110453 110454 110455 110456 110457 110458 110459 110460 110461 110462 110463 110464 110465 110466 110467 110468 110469 110470 110471 110472 110473 110474 110475 110476 110477 110478 110479 110480 110481 110482 110483 110484 110485 110486 110487 110488 110489 110490 110491 110492 110493 110494 110495 110496 110497 110498 110499 110500 110501 110502 110503 110505 110507 110508 110504 110509
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - Nationwide including the states of AZ, AR, CA, FL, GA, IL, IN, KS, KY, MD, MN, NM, NY,NC, OK, OR, SD, TN, TX, UT, WA, WY, WI and WV., and the countries of AUSTRALIA, BELGIUM, CANADA, CHINA, ENGLAND, FRANCE, GERMANY, HONG KONG, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, PHILIPPINES, RUSSIA, SPAIN, TAIWAN, TURKEY, MARTINIQUE, ROMANIA, SRI LANKA and SWITZERLAND.
  • 제품 설명
    TomoTherapy Treatment System, Model: Hi-Art, Catalog/Part Number: H-0000-0003, software versions 2.0.0 and 2.0.1 (Hi-Art¿ 5.0.0 and 5.0.1). || The TomoTherapy treatment system is intended to be used as an integrated system for the 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/three dimensional conformal) format in accordance with the physicians prescribed and approved plan.
  • Manufacturer
    TomoTherapy Incorporated

Manufacturer

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