Events

Device Recall MHITM2000/ VERO" 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hitachi Ltd., Medical System Operations Group 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
    79439
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1585-2018
  • 사례 시작날짜
    2017-12-08
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162328
  • 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
    Due to a system controller software anomaly, the patient positioning deviation correction may not be applied and may result in the wrong part of the patient being irradiated.
  • 조치
    Hitachi sent a Field Safety Notice letter dated November 28, 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. The notification letter includes instructions for the user on how to verify patient position even with the software issue. The letter also explains that correction software is being developed with a tentative release date of, "End of January, 2018.". A customer service representative will contact affected customers about installing the software. For questions contact your our Customer Service Representative.

Device

Device Recall MHITM2000/ VERO"
  • 모델명 / 제조번호(시리얼번호)
    Serial Number: 203919
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution in the state of NY.
  • 제품 설명
    MHI-TM2000 Linear Accelerator System || Product Usage: || MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
  • Manufacturer
    Hitachi Ltd., Medical System Operations Group

Manufacturer

Hitachi Ltd., Medical System Operations Group
  • 제조사 주소
    Hitachi Ltd., Medical System Operations Group, 2-1, Shintoyofuta, Kashiwa Japan
  • 제조사 모회사 (2017)
    Hitachi Ltd
  • Source
    USFDA