Events

neoBLUE blanket LED Phototherapy SystemsDevice Numbers:007301 neoBLUE blanket LED Phototherapy System with Large blanket/pad; AUS power cord 007302 neoBLUE blanket LED Phototherapy System with Small blanket/pad; AUS power cord 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Paragon Healthcare 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-2017-RN-00043-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00043-1
  • 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
    A potential issue of discolouration/degradation/melting of the fiber optic bundle at the pad connector which is inserted in the neoblue blanket light box has been identified. the manufacturer is in the process of confirming an updated neoblue blanket configuration which will not be susceptible to the degradation issue. (please note that the date of project completion is uncertain at this time.).
  • 조치
    Paragon is requesting users to continue to check the fiber optic connection before use as described in the Technical Bulletin. Users are advised to refer to the Technical Bulletin for further important information and that they will be contacted for a replacement or upgrade when the updated configuration is available.

Device

neoBLUE blanket LED Phototherapy SystemsDevice Numbers:007301 neoBLUE blanket LED Phototherapy Sy...
  • 모델명 / 제조번호(시리얼번호)
    neoBLUE blanket LED Phototherapy SystemsDevice Numbers:007301 neoBLUE blanket LED Phototherapy System with Large blanket/pad; AUS power cord 007302 neoBLUE blanket LED Phototherapy System with Small blanket/pad; AUS power cordSerial numbers up to and including xxxx004282 ARTG Number: 97472
  • Manufacturer
    Paragon Healthcare Pty Ltd

Manufacturer

Paragon Healthcare Pty Ltd