Events

CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic Resonance Imaging) 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-2015-RN-00079-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00079-1
  • 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
    Philips is informing the customer that the lithium polymer batteries, used in the cdas upgraded intera mr systems equipped with the basic triggering unit may fail after being physically dropped from a height (i.E. from waist height to floor). the failed battery may momentarily produce a flame and then emit smoke, which could lead to a thermal burn to patient or operator in close proximity to the battery. the failure of the battery may occur instantly or may be delayed for a short period of time.
  • 조치
    Philips is providing guidelines to reduce the risk of the battery failure as well as instructions to mitigate the risk of harm in case the battery was dropped. Philips is replacing the affected batteries free of charge. This action has been closed-out on 03/08/2016.

Device

CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic R...
  • 모델명 / 제조번호(시리얼번호)
    CDAS upgraded Intera MR systems equipped with the Basic Triggering Unit(Full body MRI (Magnetic Resonance Imaging) system)Part numbers: 9065 and 9067Units Affected: All batteries with date codes 2808 or earlierARTG Number: 98887
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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