Events

Radiation Therapy 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
    49607
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0339-2009
  • 사례 시작날짜
    2008-09-18
  • 사례 출판 날짜
    2009-01-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73906
  • 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 - Product Code IYE
  • 원인
    Tomotherapy inc. discovered an issue on the hi-art system during the course of ongoing testing. it has been identified that treatment plans involving very small structures (volume <2cc), reading in a high dose gradient region, may exhibit inaccuracies with the dvh curve and the dose statistics for the small structures. this error can only happen if planning was performed using very small voxels.
  • 조치
    Consignees were sent on 9/18/08 a "TomoTherapy Incorporated Urgent Medical Device Correction Field Safety Notice" letter dated September 17, 2008. The letter described the issue, product affected, recommended actions and resolution. Questions may be directed to TomoTherapy Inc. Customer Service Center at 1-868-368-4807.

Device

Radiation Therapy System
  • 모델명 / 제조번호(시리얼번호)
    USA 110001 110002 110003 110004 110005 110006 110007 110008 110012 110015 110016 110019 110020 110021 110023 110026 110027 110028 110029 110030 110031 110032 110033 110035 110038 110040 110042 110043 110044 110045 110047 110048 110050 110051 110053 110054 110056 110057 110059 110060 110067 110073 110074 110082 110084 110086 110087 110089 110090 110092 110094 110095 110096 110097 110098 110103 110105 110106 110108 110112 110115 110116 110118 110119 110120 110122 110127 110132 110134 110135 110138 110139 110149 110152 110153 110154 110155 110158 110160 110161 110165 110166 110168 110173 110174 110175 110176 110177 110179 110180 110181 110185 110186 110187 110188 110190 110192 110193 110195 110196 110197 110198 110201 110202 110203 110204 110206 110209 110210 110213 110215 110216 110217 110221 110222 110223 110224 110225 110227 110242 and 110250  OUS 110034 110062 110083 110126 110140 110014 110037 110072 110130 110169 110137 110077 110111 110117 110123 110146 110151 110189 110114 110131 110143 110170 110061 110167 110228 110157 110018 110071 110136 110162 110171 110211 110199 110150 110178 110237 110068 110078 110194 110069 110110 110191 110207 and 110240
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    AK AL AR AZ CA CO CT DC FL HI IA IL IN KY LA MA MD MI MN MO NE NJ NM NV NY OH OK OR PA PR SC SD TN TX VA WA WI and WY Belgium Canada Switzerland Germany Spain France Great Britain India Italy Japan Korea Netherlands Turkey and Taiwan
  • 제품 설명
    TomoTherapy HI-ART Systems with 3.1.2, 3.1.3 or 3.2.1 software. The affected applications include Planning Station, Planned Adaptive, Data Management System, and TomoPortal. The product is intended for use in radiation therapy.
  • Manufacturer
    TomoTherapy Incorporated

Manufacturer

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