Events

Device Recall Elekta Impac Software Sequencer 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
    55712
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0159-2011
  • 사례 시작날짜
    2010-02-19
  • 사례 출판 날짜
    2010-10-28
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-03-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91633
  • 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
    Mistreatment-- the database conversion utility used during the upgrade errantly changes the start gantry angle to zero. any affected treatment fields, if not already treated, would start delivering from zero instead of the original prescribed value.
  • 조치
    ELEKTA IMPAC SOFTWARE sent a USER NOTICE dated February 19, 2010, to all customers. The notice identified the product, the problem, and the action to be taken by the customers. Customers were urged to verify the start angle of the gantry against the treatment field definition prior to delivery. Review all treatment plans and charts with conformal arcs. If a treatment plan with an errant gantry start angle was identified, customers were to cease using that plan immediately. A workaround was to be re-imported into their current version of MOSAIQ. IMPAC Support was to follow-up with each site and execute a script to detect and correct all affected treatment plans. For questions, concerns, and requests for upgrade, customers were to email support@impac.com or call their support center.

Device

Device Recall Elekta Impac Software Sequencer
  • 모델명 / 제조번호(시리얼번호)
    Sequencer for MOSAIQ 1.60W3 (including all service packs), 2.00T2 (inclusing all service packs), 2.10L5 (including all service packs) and 2.10M7 (including all service packs).
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Australia, Belgium, France, Germany, Hong Kong, Ireland, Israel, and Italy
  • 제품 설명
    Elekta Impac Software Sequencer Verify & Record System, for MOSAIQ, manufactured by Elekta Impac Software, Sunnyvale, CA. || The intended use of Sequencer (generically referred to as a verification system) is to assist in the process of process of patient treatment on a radiotherapy treatment machine.
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

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