Events

Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area) 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-2012-RN-01019-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2012-10-03
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01019-1
  • 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
    The manufacturer has become aware of a case in which the monitor support bracket has detached from the joint pin at the bottom of the height adjustable ac3000 spring arm and fallen down together with the monitor until it was only held by the electrical cable connections. an inspection of a further seven monitor brackets in the same hospital identified severe wear on the ring groove responsible for the joint pin. investigation showed that the support shoulder of the locking element in the aluminum pin's groove is too low in an unfavorable tolerance position. the frequent movement of the arm under load may cause the locking element to damage the pin's groove and ultimately shear off, which may then result in the reported event.
  • 조치
    Stryker Service Technician to inspect and correct Spring Arm Circlips.

Device

Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the ...
  • 모델명 / 제조번호(시리얼번호)
    Spring Arm (Intended for use as a ceiling mounted device to support or position equipment in the patient area)Product numbers: 0682001270, 0682001274, 0682000226 & 06824000591Multiple lot numbers affectedARTG Number: 118878
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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