Events

Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-2012-RN-00949-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-09-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00949-1
  • 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
    When positioning the coil off centre in the left direction as it is used, for example, a hip and shoulder imaging and, in addition at an off centre position with respect to the head-foot direction, the coil can heat up on the area of the electronic housing (white plastic lids).To be more precise, heating may occur if each of the following conditions applies at the same time:- coil positioned off-center in head-foot direction by more than 5cm- coil at side position- application of higher rf power over several minutes.In that position, the surface temperature may well exceed temperatures defined by regulatory standards and may cause local burns to the patient.
  • 조치
    Siemens is providing work around instructions for users to follow.

Device

Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System)
  • 모델명 / 제조번호(시리얼번호)
    Flex Large 4 Coil for MAGNETOM Skyra, Verio, Spectra and Biograph mMR (Full body MRI System)ARTG Number: 98485
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd