ONDAL ACROBRAT SPRING ARM 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 OLYMPUS CANADA INC. 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
    66074
  • 사례 위험등급
    III
  • 사례 시작날짜
    2015-07-27
  • 사례 국가
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • 데이터 추가 비고
  • 원인
    Trumpf medical has been notified by its supplier that there is potential for fatigue fractures to develop in welds in the front joint of spring arms over time when subject to extreme forces. trumpf medical does not have complaints related to this failure mode. the supplier has advised that a visual inspection of the welded joints should be completed on a bi-annual basis (every two years) as advised in the user manual since july 2010. this inspection should therefore be occurring for all trumpf medical surgical light camera and monitor arm system spring arms.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 1528403 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1513140 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1400191 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1441784 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 1558932 (Lot serial: > 10 lot numbers contact mfg)
  • 제품 설명
    ONDAL ACROBRAT SPRING ARM
  • Manufacturer

Manufacturer