Events

Ingenuity Core128 CT System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-2016-RN-00597-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-05-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00597-1
  • 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
    During production two different length fasteners were found to be made of stainless steel rather than the specified alloy steel. the nonconforming fasteners may have been used to manufacture ingenuity ct systems. the fasteners are used to secure sub-components of the adjustment cradle within the system gantry. analysis has concluded that the nonconforming fasteners continue to meet the tensile safety factor requirements for the application. however given the material characteristics of stainless steel, these fasteners may not be re-used (re-torqued). since the adjustment cradle requires periodic adjustment, it is expected that the nonconforming fasteners would require re-torqueing at some point during the system’s lifetime. repeated re-torqueing of the stainless steel fasteners could introduce stresses that approach the ultimate yield strength of the fasteners. there have been no reports of injuries.
  • 조치
    Philips is advising users that a field service technician will replace the affected screws on all affected systems.

Device

Ingenuity Core128 CT System

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA