Events

unkown device 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 N/A 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
  • 날짜
    2004-03-15
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-raccords-equipant-des-rampes-haute-pression-centrales-d-air-medical
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    It has been detected by the technical services of AGA Medical a case of crack on a brass fitting equipping a high pressure ramp of gaseous medical air distribution unit. The company CAHOUET, manufacturer of these connections, proceeds to the removal of the parts considered potentially defective .. The ramps concerned are the following: reference CAHOUET / AGA Médica. medical air reach ramp - 1 bottle VL2135B / R61238. medical air wall ramp - 2 bottles VL2231A / R61238. medical air wall ramp - 3 bottles VL2316A / R612389. Serial numbers 64294 to 98, 64444 to 47, 65828 to 31, 66238 to 41, 66386 to 87, 66390 to 91, 77176 to 78, 77349 to 50 correspond to deliveries between April and October 2003 .. These fittings are going to be replaced as soon as possible by the authorized staff of AGA Medical who informed the institutions concerned on March 6.

Device

unkown device
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM