Events

Device Recall MOSAIQ Oncology Information Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Impac Medical Systems Inc 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
    62302
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1944-2012
  • 사례 시작날짜
    2012-06-08
  • 사례 출판 날짜
    2012-07-06
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-06-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110188
  • 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
    Impac medical became aware of a problem with the recording of the wedge motor units in mosaiq when it resumes after a machine terminates/faults, the remaining wedge mu was being erroneously set to zero.
  • 조치
    A User Notice began being distributed on June 8, 2012. This will be followed by contact at each site by IMPAC support to determine if the site is affected by this issue, and if so, the upgraded version will be suggested. The Notice identified the affected device, the problem, the clinical impact, along with the interim mitigations and the final resolution. Users are encouraged to monitor daily delivery and recordings of treatments to be sure that the Wedge Motor Units treatments are properly delivered. The letter also recommends that treatment charts be checked weekly and that users not override any parameters in MOSAIQ until the machine setup has been completed. Users are to contact Elekta Support for the upgrade.

Device

Device Recall MOSAIQ Oncology Information Systems
  • 모델명 / 제조번호(시리얼번호)
    Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
  • 제품 설명
    MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. || An image enabled electronic medical record system used for oncology workflow management. || Manufactured by: || Impac Medical Systems || 100 Mathilda Place, 5th floor || Sunnyvale, Ca 94086
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc
  • 제조사 주소
    Impac Medical Systems Inc, 100 Mathilda Place, 5th Floor, Sunnyvale CA 94086-6076
  • 제조사 모회사 (2017)
    Impac Medical Systems Inc
  • Source
    USFDA