Events

Radiolucent Spine Surgery Frame 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getinge 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-2018-RN-00024-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00024-1
  • 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
    Getinge has become aware of a potential risk, which could result in critical harm to the patient if the base of the product were to crack during use. since the introduction of this product in march 2017, one complaint with no allegation of injury has been reported where the base of the frame cracked as the patient was being prepared for surgery.
  • 조치
    Getinge Australia is advising customers to immediately remove the Spine Frame from use that are in the serial number range as identified. Getinge Australia representative will contact users to arrange the corrective repair.

Device

Radiolucent Spine Surgery Frame
  • 모델명 / 제조번호(시리얼번호)
    Radiolucent Spine Surgery Frame Material Number: 100731AOModel Number: F-70801Multiple Affected Serial NumbersARTG 236335
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd