Digital Accelerators with iViewGT or XVI 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-2017-RN-01480-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-12-04
  • 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
    Elekta has identified that if the microswitch in the pcb assembly, solenoid limit switch of the middle arm is not set up correctly, it is possible to get an uncontrolled extension of mv or kv detector arms. it is possible that a collision with the extended arm can cause serious injury. when the detector arm is fully extended there is no risk.
  • 조치
    Recommended User Action: Elekta recommends that the user does not open or close the detector arm when it is positioned above the patient, as specified in the Instructions for use (IFU). iViewGT Elekta recommends that the detector panel is not opened or closed when the gantry is at 180° (±45°), especially when a patient is on the treatment table. The movement of the MV detector panel at these angles can disturb a patient if they are below the detector panel. XVI Elekta recommends that you do not open or close the detector arms when they are in a position above the patient. Distribute the supplied notice to all users of the system at your facility. Include a copy of the supplied notice with the system manuals. To acknowledge the receipt of this letter please complete the Confirmation of receipt form you receive from Elekta's automated distribution system. Return the form even if you no longer have the affected units at your site.

Device

  • 모델명 / 제조번호(시리얼번호)
    Digital Accelerators with iViewGT or XVI ARTG number: 111760
  • 의료기기 분류등급
  • Manufacturer

Manufacturer