Events

Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure) 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-2014-RN-00829-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-25
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00829-1
  • 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 contact electrostatic discharge (esd) is applied to one of the four screws on the rear enclosure panel of the ip5, the wireless function of the ip5 radio could be interrupted. if this were to occur, there could be a loss of wireless communication between the ip5 and host monitoring system, the expression mri patient monitoring system or the expression mr200 mri patient monitoring system. this could potentially lead to a delay in treatment or diagnosis of the patient.
  • 조치
    A Philips representative will contact affected customers to arrange for the addition of two ferrite clamps to a cable located inside the device to protect against an electrical pulse from ESD. Philips has advised that the IP5 can continue to be used and have provided work around instructions to reduce the risk of electrical pulse from ESD. This action has been closed-out on 1/06/2016.

Device

Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)
  • 모델명 / 제조번호(시리얼번호)
    Expression IP5 Information Portal (Multiparameter patient monitor for use during MRI procedure)Product Code: 865471 Serial Numbers: US23200375, US23200376, US23200377ARTG Number: 189095
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

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