Events

Linet Eleganza Standard and Deluxe Model Bedframes 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Linet Spol s.r.o. 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
    SN2011(20)
  • 날짜
    2011-08-12
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/linet-eleganza-standard-and-deluxe-model-bedframes&id=9383f825-9782-6eee-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
    Linet has become aware that certain bedframes are susceptible to developing cracked or damaged welds in one particular area of the bedframe.
  • 조치
    Linet has confirmed that this issue is confined to bedframes manufactured up to December 2005 (see FSN for affected serial numbers). To date, Linet has been unable to obtain full traceability for affected devices potentially distributed in Ireland.  The IMB advises that users:  • Identify the affected devices in your facility.  • If you have affected devices, follow the manufacturer’s recommendations, as outlined in the attached FSN, and contact Linet to arrange for modification.

Device

Linet Eleganza Standard and Deluxe Model Bedframes
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Linet Eleganza Standard and Deluxe Model Bedframes
  • Manufacturer
    Linet Spol s.r.o.

Manufacturer

Linet Spol s.r.o.