Events

neoBLUE LED Phototherapy Lights (2nd Generation) 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-00466-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-04-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00466-1
  • 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
    The neoblue 2 systems were manufactured using individual leds of higher intensity output than the original product specification. to compensate for this higher intensity, customers were previously advised to increase the distance between the phototherapy light and the patient. the neoblue 2 light is now being recalled and replaced with the current generation light.
  • 조치
    Paragon Care is requesting customers identify if they have affected stock by checking for a black band around the light enclosure base. If so, users are requested to record the Serial number (located on the back panel of the light enclosure) on the reply form and return the completed form in order to receive a free replacement. Users are then advised to place the affected light in the box which contained the replacement prior to its return to Paragon Care.

Device

neoBLUE LED Phototherapy Lights (2nd Generation)
  • 모델명 / 제조번호(시리얼번호)
    neoBLUE LED Phototherapy Lights (2nd Generation)ARTG Number: 97472
  • Manufacturer
    Paragon Healthcare Pty Ltd

Manufacturer

Paragon Healthcare Pty Ltd