Events

VITROS 5600 Integrated System. An in vitro diagnostic medical device (IVD) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ortho-Clinical Diagnostics 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-00228-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-02-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00228-1
  • 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
    Ortho is providing information regarding the potential for four wires connected to the power supply to have been misconfigured within vitros 5600 system(s) during manufacturing. the electrical wires are located in an area that is intended to be accessed only by an ortho-trained service representative. normal use, maintenance and troubleshooting on vitros 5600 system will not expose an operator to electrical hazards as a result of this issue.If a system has the incorrect wire configuration, it is possible that if the power to an individual module is intended to be shut off, it will remain on. however, there is no risk to ortho-trained service personnel if they follow normal procedures and power off the appropriate module or the vitros 5600 system as a whole prior to working on a component.
  • 조치
    Customers are advised that there is no impact to the results generated with an affected system. An Ortho representative will be inspecting the wiring of all affected systems and will reconfigure the wiring where required. This action has been closed-out on 09/05/2017.

Device

VITROS 5600 Integrated System. An in vitro diagnostic medical device (IVD)
  • 모델명 / 제조번호(시리얼번호)
    VITROS 5600 Integrated System. An in vitro diagnostic medical device (IVD)Product Codes: 6802413 and 6802915ARTG Number: 180199
  • Manufacturer
    Ortho-Clinical Diagnostics

Manufacturer

Ortho-Clinical Diagnostics