Maquet Heater-Cooler Unit HCU 40 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Maquet 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-2017-RN-00904-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-07-24
  • 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
    Maquet cardiopulmonary has developed and validated new and revised cleaning and disinfection procedure for hcu 40 including a routine disinfection protocol and a protocol for highly effective disinfection also effective against atypical mycobacteria in the water system to be implemented on all hcu 40 systems in the field.This update also includes the following actions:1. replacement of valves:existing valves will be replaced by successors with proven material compatibility with the new cleaning and disinfection procedure;2. replacement of flow sensors:in hcu 40 devices with serial number below 90440266 the mechanical flow sensor will also be replaced by its successor to ensure material compatibility with the new cleaning and disinfection procedure; and3. software update release 1.2.3.0:hcu 40 devices will be updated with the new software (release 1.2.3.0) including a new cleaning wizard guiding the user through the new cleaning and disinfection process step by step.
  • 조치
    Actions to be taken by users: 1. The update on HCU 40 systems has to be performed by authorised Maquet service personnel according to the Update Instruction as soon as possible; 2. Fill out the supplied Acknowledgement Form and return it as soon as possible to your local Maquet representative; 3. Incorporate the new cleaning and disinfection procedures into operating processes, and conduct any necessary training; 4. Continue to monitor the hygiene (contamination levels) in accordance with internal practices; and 5. Immediately report any contamination findings to the local Maquet representative by filing a complaint.

Device

  • 모델명 / 제조번호(시리얼번호)
    Maquet Heater-Cooler Unit HCU 40All Serial Numbers below 90441000ARTG Number 144010
  • Manufacturer

Manufacturer