Steris Amsco Warming Cabinet; War Cab Pre Glass Dual 24" 230V mobile; War Cab PTD Glass SGL 18” 230V 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Device Technologies 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-2016-RN-00043-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-01-12
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Steris has identified that some information printed on the quick reference magnet is incorrect; specifically, fahrenheit to celsius temperature conversions and the default warming cabinet temperature. it should be noted that all temperature information in the warming cabinet operator manual is correct. the risk to patients/users due to the reported issue is negligible.
  • 조치
    The sponsor is advising users to discard the existing quick reference magnet and refer to the manual until the replacement quick reference magnet is received.

Device

  • 모델명 / 제조번호(시리얼번호)
    Steris Amsco Warming CabinetWar Cab Pre Glass Dual 24" 230V mobileProduct Code: ST-DJ06014433112Serial Numbers: 0408215020 and 0408215021War Cab PTD Glass SGL 18” 230VProduct Code: ST-DJ050144132Serial Numbers: 0423315089ARTG Number: 167720
  • Manufacturer

Manufacturer