Events

Leica tissue processor 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Leica Biosystems Nussloch Gmbh 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    I1509-456
  • 사례 연번
    2014DM-0012120
  • 날짜
    2015-09-29
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=170
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer establishes that the internal wiring of the remote alarm plug in the referenced medical devices may be incorrect, which may cause the remote control not to work properly in case of failure of the instrument, the loss of the alarm could lead to improper processing of the shows, which could lead to re-interventions and potential adverse events on the patient.

Device

Leica tissue processor
  • 모델명 / 제조번호(시리얼번호)
    ASP200 and ASP300S, with serials 5259, 5260, 5264, 5266, 5267, 5272, 5273, 5289, 5301, 5310, 5348, 5349, 5356, || 5366, 5381, 5385, 5386, 5387, 5388, 5398, 5401, 5403, || 5407, 5416, 5426, 5434, 5435, 5446, 5530, 5562, 5609, || 5610, 5612, 5663, 5670, 5673, 5682, 5693, 5706, 5724, || 5725, 5734, 5737, 5794, 5796, 5798, 5799, 5804, 5807, || 5815, 5871, 5873, 5874, 5875, 5886, 5889, 5909, 5926, || 5929, 5946, 5947, 5948, 5955, 5956, 5962, 5965, 5977, || 6000, 6015, 6021, 6040, 6041, 6042, 6045, 6046, 6062, || 6115, 6131, 6149
  • 제품 설명
    Only qualified personnel should use the tissue processor. The equipment has been designed in such a way that it is fault-proof - both in terms of the user and the samples to be processed - provided that the user complies at all times with the instructions in the user manual. The equipment has been designed for the following laboratory applications: • fixation, • dehydration, • paraffin infiltration of histological samples.
  • Manufacturer
    Leica Biosystems Nussloch Gmbh

Manufacturer

Leica Biosystems Nussloch Gmbh