Events

CARTO® 3 Interface Cable 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 ETHICON SAS;CORDIS SAS;Johnson-Johnson 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
    2010-10-22
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/cable-d-interface-carto-r-3-reference-catalogue-cr3410ct-biosence-webster-inc-retrait-de-lots
  • 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
    On 20/10/2010, the company: ETHICON SAS - CORDIS SAS Johnson-Johnson compagny, has withdrawn from the market all batches of the reference CR3410CT, of the medical device called "CARTO® interface cable", manufactured by: BIOSENCE WEBSTER Inc. Biosense Webster has determined that crossing the electrical signal in the cable can contribute to loss or distortion of surface ECG signals when using this cable. This is due to the presence of an electrical wire connecting two pins inside the connector of the interface cable with the CARTO® 3 system, which can cause a short circuit at the analog ground of the CARTO® 3 system. This short-circuit can also generate a low continuous electrical current when a CELSIUS ® DS catheter is connected. The company ETHICON SAS - CORDIS SAS has directly notified the recipients of the incriminated lots with the enclosed message validated by the Afssaps (22/10/2010) (160 ko) .. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

CARTO® 3 Interface Cable

Manufacturer

ETHICON SAS;CORDIS SAS;Johnson-Johnson
  • Source
    LAANSM