Events

Navigational System II - Cart(Surgical navigation system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker Australia 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-2015-RN-00619-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-07-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00619-1
  • 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
    Between may 2012 and july 2014, ondal medical systems gmbh received three complaints from customers where a broken joint of the articulated arm was reported. for two of the complaints the parts failed directly after installation of the device, for the other complaint, the part failed after six months. the load attached to the arm was in all three cases was approximately 18 kg.Additional inspection is required because there is a potential that the weld seam between the main stud and the two flaps on the articulated arm was not welded in the correct location, which may result in a potential failure of the arm joint.
  • 조치
    Stryker is requesting hospitals to check all stock areas and/or operating room storage and quarantine all affected equipment. A Stryker Representative will contact your facility to set up a time to perform the additional inspection of the weld seam on the Navigation System II-Cart, Articulated Arm Camera. This action has been closd-out on 15/08/2016.

Device

Navigational System II - Cart(Surgical navigation system)
  • 모델명 / 제조번호(시리얼번호)
    Navigational System II - Cart(Surgical navigation system)Catalogue number: 7700-100-000Cart Serial Number: 100968, 100969Arm Serial Number: 11102258470, 11102258469ARTG Number: 127497
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA