Runyes Autoclave17L, 22L B Class Manufactured between 2012 & 2017 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medical Equipment 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-2018-RN-00001-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-12
  • 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
    Medical equipment australia has been made aware of an issue regarding the failure of cycles when the negative pressure is not within a specified range. affected devices will be provided with a software update to rectify the issue of monitoring critical parameters during a cycle and generate a 'fail' if they are not reached.
  • 조치
    Medical Equipment Australia will arrange a service technician to be in contact with users to arrange for software upgrade to correct this issue. In the interim, users should refer to the tests outlined in the customer letter to verify that their equipment is functioning correctly.

Device

  • 모델명 / 제조번호(시리얼번호)
    Runyes Autoclave17L, 22L B ClassManufactured between 2012 & 2017Multiple Affected Serial NumbersARTG Number: 197900 (Medical Equipment Australia Pty Ltd - Sterilizer, moist heat, fluid)
  • Manufacturer

Manufacturer