Events

Marus Brand LuxStar Dental Lights 에 대한 현장 안전성 서한

Health Products Regulatory Authority에 따르면, 해당 현장 안전성 서한 는 Ireland 에서 Marus 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(26)
  • 날짜
    2011-11-16
  • 사례 국가
    Ireland
  • 사례 출처
    HPRA
  • 사례 출처 URL
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/marus-brand-luxstar-dental-lights&id=c381f825-9782-6eee-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
    Marus has become aware that the lens heat (bulb) shield (birdcage) on the marus luxstar dental lights, model ol1000, may potentially fall off the dental light if not properly installed after replacing the light bulb, or if not properly maintained.
  • 조치
    Marus has been unsuccessful in their attempts to locate all devices affected by this field safety corrective action (FSCA), as one of the distributors in Ireland, Dacus Dental, has ceased trading. The serial numbers of the devices provided to Dacus Dental are 4714B and 165569B.  The IMB advises that users:  • Identify the affected devices in your facility.  • Ensure the appropriate personnel are made aware of this notice.  • If you (or your facility) have affected devices, follow the recommendations outlined in the attached Field Safety Notice and contact Marus to obtain the self-installation kit.

Device

Marus Brand LuxStar Dental Lights
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Marus Brand LuxStar Dental Lights
  • Manufacturer
    Marus

Manufacturer

Marus