Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy and simulation use.) 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-2014-RN-00927-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-08-22
  • 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 have identified that it is possible to get a positional error with the precise treatment table. this can occur if the positional sensors are not correctly installed during corrective maintenance. the system has a software check for large positional errors which is intended to find faults, but it is possible to position the treatment table with errors greater than 5mm and no inhibits are displayed. it is possible to cause a clinical mistreatment if the patient is not in the correct position.
  • 조치
    Elekta recommends the customers to verify the accuracy of the treatment table position using the procedure as shown by the treatment room monitor (TRM) as part of the daily machine checks. Elekta will supply an improved method of check/test for service engineers to implement post maintenance on the potentiometers to ensure they have correctly installed the positional sensors. This action has been closed-out on 12/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Precise Treatment Table ( A patient treatment support and positioning table for radiation therapy and simulation use.) Serial Numbers: 124001-125803, 125807-880, 125883-899, 125902-917, 125920-949, 125952-963, 125967-125153, 126158-170, 126174-208, 126212-230, 126232-261, 126269-281, 126293-309,126318-330, 126338-126373, 126375-397, 126400-133999 & 213000+ARTG Number: 165045
  • Manufacturer

Manufacturer