Events

Liko FreeSpan Traverse & FreeSpan Ultra Twin Traverse Freestanding Lift Systems 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Liko 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 연번
    SN2014(07)
  • 날짜
    2014-02-25
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/liko-freespan-traverse-freespan-ultra-twin-traverse-freestanding-lift-systems&id=2978f825-9782-6eee-9b55-ff00008c97d0
  • 비고 / 경고
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • 데이터 추가 비고
  • 원인
    Hill-rom has identified that information in the instructions guide dated the 7th november 2007 and earlier for the freespan traverse & freespan ultra twin traverse freestanding lift systems is not clear regarding maximum overhang allowed for the systems.
  • 조치
    The IMB advises that users:  (1) The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation, including those who maintain lifting systems and to any other persons/organisations where these devices have been transferred.  (2) Identify the location of all affected lifting systems.  (3) If you / your institution have any affected lifting systems, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and examine the set-up of the lifting system.

Device

Liko FreeSpan Traverse & FreeSpan Ultra Twin Traverse Freestanding Lift Systems
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Liko FreeSpan Traverse & FreeSpan Ultra Twin Traverse Freestanding Lift Systems
  • Manufacturer
    Liko

Manufacturer

Liko