STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to final disinfection and sterilisation) 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-2015-RN-00323-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-04-13
  • 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 learned through customer feedback and field service experience that should the caviwave pro ultrasonic cleaning system experience a temporary interruption in electrical power during a processing cycle, it is possible that the circulation pump or ultrasonic generator may stop functioning. the machine does not provide an alert notifying the user of this device malfunction. no injuries or adverse health outcomes have been reported due to this issue.
  • 조치
    Device Technologies representative will contact customers to arrange an upgrade to correct the problem. Customers may continue to operate all Caviwave Pro Ultrasonic Cleaning System and are advised that if they experience a malfunction prior to the upgrade, the equipment in the cycle should be reprocessed. This action has been closed-out on 19/08/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    STERIS Caviwave Pro Ultrasonic Cleaning System (used to wash instruments and accessories prior to final disinfection and sterilisation) Product codes: ST-CRP1172 and ST-CRP1172401 ARTG number: 158370
  • Manufacturer

Manufacturer