Events

Standard SlingBar 450Distributed between January 1980 and November 2012 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hill-Rom 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-2013-RN-00477-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-09-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00477-1
  • 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
    Hill-rom has become aware of a safety issue related to the standard slingbar 450, which could be attached to various liko overhead and mobile lifts. a serious injury to a patient, caregiver, or bystander could result from tripping or otherwise falling in to the slingbar, typically while the lift is parked or stored when not in use. the sling hook on the other end of the sling bar could pierce a body structure such as the head, shoulder, or groin.
  • 조치
    Hill-Rom is providing customers with a sling-bar safety cover to mitigate the risk of patient or user injury. For more details, please see http://www.tga.gov.au/safety/alerts-device-standard-slingbar-450-131001.htm .

Device

Standard SlingBar 450Distributed between January 1980 and November 2012
  • 모델명 / 제조번호(시리얼번호)
    Standard SlingBar 450Distributed between January 1980 and November 2012Product numbers: 20090029, 20190024, 20190041, 31190015, 31290017, 31290043, 3156001, 3156003, 3156007, 3156014, 3156016, 31590043 & 5019013These product numbers may be bundled with the Golvo 1000, 3000 and 7000 series lifts, Viking M, Viking L, LikoLight 100 and 125, Caroli 101, and Uno 100, 101 and 102ARTG Number: 188199
  • Manufacturer
    Hill-Rom Pty Ltd

Manufacturer

Hill-Rom Pty Ltd