Events

Test Tube Heater - Power Supply UnitTest Tube Heater 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook Australia 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-2014-RN-00924-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-08-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00924-1
  • 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 power supply of the devices are being replaced because recent testing of the combination of the test tube heater and power supply was found to exceed the prescribed electromagnetic compatibility (emc) limits for radiated emissions.As the level of excess emissions are only slightly over the prescribed limits, and because the exposure to the radio frequency (rf) fields is far below internationally accepted safety levels, it is unlikely that there are any health risks to the user or patient posed by the non-conforming combination of the test tube heater (k-fth-1012) and power supply (k-aps-300). it is also unlikely for the power supply to affect the operation of the test tube heater as this device is designed to have rf immunity greater than the radiation emitted by the power supply.
  • 조치
    William A. Cook Australia will provide an alternative power supply unit. End users are requested to discontinue use and destroy the affected units. This action has been closed-out on 01/03/2016.

Device

Test Tube Heater - Power Supply UnitTest Tube Heater
  • 모델명 / 제조번호(시리얼번호)
    Test Tube Heater - Power Supply UnitTest Tube Heater Part Number: K-FTH-1012Power Supply Unit Part Number: K-APS-300ARTG Number: 140546
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd