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
    56166
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2219-2010
  • 사례 시작날짜
    2009-12-01
  • 사례 출판 날짜
    2010-08-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92786
  • 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
    System, planning, radiation therapy treatment - Product Code MUJ
  • 원인
    An issue was identified with the tomotherapy hi-art system. in the event a patient or dqa plan has a moved image, roll adjustments applied during registration will be incorrect. the planning station plan settings and dqa setup tabs allow for images to be moved during planning. during registration when roll is applied on moved images, the operator station incorrectly rolls the image about.
  • 조치
    Consignee was sent a TomoTherapy "Urgent Medical device Correction Field Safety Notice' dated December 01, 2009. The letter described the Issue, Product Affected, Recommended Action and Resolution.

Device

Device Recall TomoTherapy HIART System
  • 모델명 / 제조번호(시리얼번호)
    110019
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    VA
  • 제품 설명
    Hi-Art System, H-0000-0003 || Usage: The TomoTherapy Hi-Art 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 tissue. 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 physician approved plan
  • Manufacturer
    TomoTherapy Incorporated

Manufacturer

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