Events

Alerte De Sécurité sur Angiography X-ray System: (1) LC +, (2) LCA, (3) LCA +, (4) LCLP +, (5) LCN +, (6) LCV +. Models Nos: 2120351, 2120351-2, 2219157, 2279157-2, 2251041, 2154096, 2219156, 2251039; all the. (internationally)

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par GE Medical Systems; GE Medical Systems Europe.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    368
  • Date
    2002-01-09
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The c-arm of the above x-ray system can move quickly, forcing the collimator down the table. the distributor initiated a correction, modifying the instructions, by letter dated april 1, 2001, distributed to its service engineers.
  • Action
    The distributor states that all US and Canadian units are being corrected and that most units internationally have already been corrected. If you have not been consulted for repair, or for more information, contact your local GE Medical Systems service provider. ANVISA has provided the Forms of Notifications of Occurrences on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory

Device

Angiography X-ray System: (1) LC +, (2) LCA, (3) LCA +, (4) LCLP +, (5) LCN +, (6) LCV +. Models ...

Manufacturer

GE Medical Systems; GE Medical Systems Europe
  • Source
    ANVSANVISA