Events

Device Recall TomoTherapy HiArt 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
    46965
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1615-2008
  • 사례 시작날짜
    2008-02-22
  • 사례 출판 날짜
    2008-08-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-12-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68635
  • 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
    Medical Linear Accelerator - Product Code IYE
  • 원인
    Registration adjustment field numbers may appear on printed pages of the register tab as nonsense characters or values different than the numbers shown on the operator station (os) display. setup will move the couch to the correct offset position. if the couch is manually adjusted to the incorrect value, the patient may not be the correct position during treatment.
  • 조치
    Consignees were sent a letter "TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice" dated February 22,2008. The letter described the Issue, Product Affected, Cause, Recommended Customer Action and Resolution. If you have not received this letter or have questions, contact the firm as outlined below: North America: 1 866 368 4807 Belgium: 0800 38783 France: 0805 631 565 Germany: 0800 000 7541 Italy: 800 986 399 Netherlands: 0800 0201364 Spain: 800 300049 Switzerland: 0800 001927 United Kingdom: 0808 238 6035 China/CNC (Northern): 10 800 712 1701 China (Southern): 10 800 120 1701 Hong Kong: 800 967912 Japan: 0044 22 132374 Singapore: 800 1204 683 South Korea: 0079 81 4800 7204 All other locations: +1 608 824 2900 or +32 2 400 44 44

Device

Device Recall TomoTherapy HiArt System
  • 모델명 / 제조번호(시리얼번호)
    10002 10003 10007 10016 10019 10021 10028 10037 10044 10048 10050 10051 10056 10094 10165 10166 10168 10169 10174 10185 10186 10187 10188 10189 10190 10191 10192 10193 10194 10195 10196 10198
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of CA ,CT, DC, FL, IL, LA, MD, MI, MO, NE, NJ, NY, SC, TN, VA, WI , and countries of Canada, Germany, Taiwan, and Turkey.
  • 제품 설명
    TomoTherapy Hi-Art System with software versions 3.0 and 3.1 - Radiation Therapy System. The device is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy.
  • Manufacturer
    TomoTherapy Incorporated

Manufacturer

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