Events

Surgical Instruments 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 GEM Universal Industry 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
    2014-02-05
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/instruments-de-chirurgie-gem-universal-industrie-retrait-de-produit
  • 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
    Information for local correspondents of materiovigilance, directors of health facilities, surgery and pharmacy. ANSM has decided to suspend the placing on the market, commissioning, importing, exporting and distributing of these products until they are brought into compliance, as well as stopping the use and withdrawing them. Re-usable surgical instruments from the Titanox range marketed by GEM Universal Industrie. For these medical devices, the company does not have a CE marking file compliant. The users concerned have received the attached mail (05/02/2014) (33 KB). Read auss. Surgical instruments put on the market by the company GEM Universal Industrie: Withdrawal and suspension of placing on the market - Information point (05/02/2014) (0 ko) Animal health decision of 28/01/2014 suspending placing on the market, putting into service, importing, exporting, distributing and using surgical instruments, sterilizers and tensiometers placed on the market by GEM Universal Industries, as well as the withdrawal of these products (05/02/2014) (355 ko)

Device

Surgical Instruments

Manufacturer

GEM Universal Industry