Events

ARTIS Zeego (Fluoroscopic angiographic x-ray system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Siemens 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-2014-RN-00383-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-04-01
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00383-1
  • 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
    Siemens healthcare has determined that the crimping of motor connectors a1 to a3 may have been incorrectly carried out. incorrectly executed crimping where the crimping tool was used on the wrong point of the crimp contact has led to substandard contacting. the resulting increase in interference resistance can cause heat build up and potentially lead to scorching of the corresponding cables.
  • 조치
    Siemens will be inspecting the connectors to ensure they are correctly crimped at the A1 to A3 motor terminals. A Siemens representative will be in touch to schedule the visit.

Device

ARTIS Zeego (Fluoroscopic angiographic x-ray system)
  • 모델명 / 제조번호(시리얼번호)
    ARTIS Zeego (Fluoroscopic angiographic x-ray system)Serial number of the motor connectors lower than 946925
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd