Events

VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series. Manufactured by Varian Medical Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Varian Medical Systems 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
    29005
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0976-04
  • 사례 시작날짜
    2004-05-04
  • 사례 출판 날짜
    2004-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2005-03-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32958
  • 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, Applicator, Radionuclide, Remote-Controlled - Product Code JAQ
  • 원인
    Manufacturer of brachytherapy instrument issued a customer technical bulletin to clarify instructions for use of the radiation treatment medical device by healthcare practitioners.
  • 조치
    The recalling firm notified end users by letter and Customer Technical Bulletin on 5/4/04. The notification informed users not to use the Emergency retract hand wheel to recover a dummy wire and to reinforce the instructions already in the procedures that in the event of an Active wire becoming stuck out, the user should not turn the emergency retract hand wheel in excess of 20 times, or until the wire has parked and the radiation alarm has silenced. Advised of proper procedures for retracting the active wire and a warning concerning excessive turning of the emergency retract handwheel. The notification also states that customer user manuals and handwheel labeling will be updated at next service visit.

Device

VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series. Manufactured by Varian Me...
  • 모델명 / 제조번호(시리얼번호)
    Config ID/Serial# (Domestic) ACC01220 VS00014 VS00015 VS00016 VS00017 VS00025 VS00028 VS00029 VS00034 VS00036 VS00037 VS00045 VS00047 VS00048 VS00049 VS00050 VS00051 VS00052 VS00053 VS00054 VS00055 VS00058 VS00064 VS00065 VS00066 VS00067 VS00068 VS00070 VS00072 VS00075 VS00076 VS00077 VS00078 VS00082 VS00083 VS00084 VS00085 VS00086 VS00089 VS00095 VS00204 VS00205 VS00207 VS00208 VS00209 VS00210 VS00212 VS00214 VS00215 VS00217 VS00219 VS00220 VS00221 VS00222 VS00223 VS00225 VS00226 VS00227 VS00230 VS00231 VS00232 VS00233 VS00234 VS00236 VS00237 VS00238 VS00243 VS00245 VS00246 VS00251 VS00253 VS00255 VS00256 VS00257 VS00258 VS00261 VS00262 VS00265 VS00266 VS00268 VS00271 VS00276 VS00281 VS00282 VS00283 VS00286 VS00287 VS00288 VS00289 VS00292 VS00296 VS00298 VS00299 VS00300 VS00300-1 VS00302 VS00303 VS00304 VS00305 VS00306 VS00307 VS00309 VS00310 VS00311 VS00314 VS00315 VS00316 VS00317 VS00318 VS00319 VS00320 VS00321 VS00322 VS00323 VS00325 VS00326 VS00327 VS00328 VS00329 VS00330 VS00331 VS00332 VS00333 VS00334 VS00336 VS00337 VS00340 VS00341 VS00342 VS00343 VS00344 VS00345 VS00347 VS00348 VS00349 VS00350 VS00352 VS00355 VS3184177491000 VS3184191051000 VS3184610861000 VSBASSETT VSSTBERNADINESS VSSTOCK
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The medical devices for correction had been distributed to medical facilities nationwide and internationally.
  • 제품 설명
    VariSource High Dose Rate Afterloader, Models 200, 200t, and ID series. Manufactured by Varian Medical Systems
  • Manufacturer
    Varian Medical Systems

Manufacturer

Varian Medical Systems
  • 제조사 주소
    Varian Medical Systems, 700 Harris St, Suite 109, Charlottesville VA 22903-4584
  • Source
    USFDA