Volume Imaging System (XVI), software versions 4.2.1 (Electronic Imaging Device (EID) used with radiation therapy treatment) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Elekta Pty Ltd 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
    RC-2013-RN-01291-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-12-03
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Xvi can incorrectly calculate the target position of the treatment table, because of an error due to a specific sequence of events that does not occur very frequently.If the user does not monitor the patient and treatment table movements, and keeps the table automatic setup (asu) buttons pressed, the treatment table continues to move potentially resulting in a fatal collision with the patient. it only stops when a touchguard activates. this error can cause a collision between the patient and an external beam limiting device (bld) if:- the external bld does not operate with the touchguard attached, or - the external bld extends out more than the touchguard. when the error occurs, it is not possible to get the table move assistant values in tolerance. therefore, it is not possible to apply an incorrect correction to the patient position before treatment delivery.
  • 조치
    Elekta is providing work around instructions for users to follow. Elekta is advising users to monitor the Actual column of the Table Move Assistant dialog box. If the Actual is blank, do not press the ASU button on the function keypad (FKP). To correct the error, users are advised to restart the XVI, place patient in initial set up position and scan the patient again and continue the usual workflow. A software update is expected to be released in April 2014 for upgrading all XVI 4.2.1 users to XVI 4.2.2 to resolve this issue. This action has been closed-out on 17/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Volume Imaging System (XVI), software versions 4.2.1 (Electronic Imaging Device (EID) used with radiation therapy treatment)ARTG Number: 214673
  • 의료기기 분류등급
  • Manufacturer

Manufacturer