Aptio Automation Modules. An in vitro diagnostic medical device (IVD). 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens Healthcare 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-01310-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-10-10
  • 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
    An issue has been identified with the aptio automation modules. there is a possibility that the plug used to connect the automation system power source may overheat and fail. the plug used to connect to a standard power outlet is not affected.
  • 조치
    Siemens is advising users to review customer letter with Medical Director, ensure all users are aware of the issue, return completed Response Form, retain letter with laboratory records and forward letter to those who may have received product. Siemens Customer Service Engineers shall be visiting customer sites to replace the power cords.

Device

  • 모델명 / 제조번호(시리얼번호)
    Aptio Automation Modules. An in vitro diagnostic medical device (IVD).Module: Refrigerated Storage ModuleMaterial Number:10703049, 10715227, 10703036, 10713762 and 10713767Module: Centrifuge ModuleMaterial Number: 10703032, 10713761 and 10713764Module: i2000SR Interface ModuleMaterial Number: 10989303 and 10989304ARTG Number: 174699
  • Manufacturer

Manufacturer