Events

Allura Systems: Field extensions Vascular R7.6 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Philips Electronics Australia 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-2015-RN-00105-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-02-06
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00105-1
  • 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
    Philips has received customer feedback where the monitor ceiling suspension (mcs) system fell to its lowest position. in this specific occasion it collided with the table top. the investigation initiated concluded that the cause of the failure was an assembly error of the actuator of the mcs. when the monitor ceiling suspension falls to its lowest position there is a possibility it might collide with patient or personnel in the room or with other equipment in close proximity of the mcs.
  • 조치
    Philips will replace all MCS actuators on affected devices. Until this action can be undertaken straps being fitted around the MCS to prevent the monitors from falling down in the event that the actuator fails. In order to avoid any risk for patients, users or bystanders are recommended the following until the containment action has been implemented: - Do not position or move the Monitor Ceiling Suspension above the patient. - Do not allow staff to stand under or close to the Monitor Ceiling Suspension. Additionally avoid any unnecessary movement of the Monitor Ceiling Suspension and inform all possible System users. This action has been closed-out on 03/08/2016.

Device

Allura Systems: Field extensions Vascular R7.6
  • 모델명 / 제조번호(시리얼번호)
    Allura Systems: Field extensions Vascular R7.6Product Code: 722134Applies to: Actuator Long Assy: 989600-184-654ARTG number: 98560
  • 의료기기 분류등급
    Radiology Devices
  • Manufacturer
    Philips Electronics Australia Ltd

Manufacturer

Philips Electronics Australia Ltd
  • 제조사 모회사 (2017)
    Philips
  • Source
    DHTGA