Events

Plates for Electrosurgical Unit Graphic Control 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 CHECK GRAPHIC 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
    2002-07-04
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/plaques-pour-bistouri-electrique-controle-graphique
  • 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
    In agreement with the AFSSAPS, the company CHECK GRAPHIC decided, a reminder of plates for electrosurgical, complementary to the one diffused on June 12 on the site of the afssaps, and sent a mail, informing of this measurement the directors and correspondences of material vigilance of the establishments concerned .. Reminder of 12 June 2002:. Part no. 0601013248: Packs n MC4301, NA34401, JA4401, AD34701, AD44701, AD54701. Reminder of July 2, 2002. Part number 0601013239: Lots MD44101 - AD2030. Code reference 0601013240: Lot MM5440. Part no. 0601013241: Lots MC44501 - AD54501 - AD14601 - AD30402 - MC24001 AD44601 - AD50402 - AD2460. Code item number 0601013242: lots RN44301 - RN30402 - RN4010. Part number 0601013248: Lots AD24201 - AD44801 - MC14401 - MC43801 - MC44301

Device

Plates for Electrosurgical Unit Graphic Control
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    CHECK GRAPHIC

Manufacturer

CHECK GRAPHIC
  • Source
    LAANSM