Events

Acuson SC200 ultrasound systems 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-00353-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-03-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00353-1
  • 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
    Due to an alignment issue with the bezel on the front panel, the plastic cover around the transducer ports prevents full contact of the connector on the transducer to the transducer port on the system. this issue causes the system to lock up.This may result in a delay in diagnosis while an alternative exam is performed.
  • 조치
    Siemens is advising users that in the event a transesophageal transducer is inserted in a patient, the user should first disconnect and reconnect the transducer. If the system still locks up, the user should then follow the instructions on the screen and disconnect the transducer, remove the transducer from the patient, and contact a Siemens service representative. Siemens will be replacing the front panel of the system as a permanent fix.

Device

Acuson SC200 ultrasound systems
  • 모델명 / 제조번호(시리얼번호)
    Acuson SC200 ultrasound systemsAffected Serial Numbers: 400300 and belowCatalogue Number: 10433816ARTG Number: 139591
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

Siemens Healthcare Pty Ltd