Events

Alerte De Sécurité sur Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par GE Healthcare.

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
  • Date
    2013-09-10
  • Date de publication de l'événement
    2013-09-10
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130910.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: ge advantx, innova 2000, innova 2100iq, innova 3100, innova 3100iq, innova 4100, innova 4100iq cardiovascular x-ray imaging systems the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning all advantx, innova 2000, innova 2100iq, innova 3100, innova 3100iq, innova 4100, innova 4100iq cardiovascular x-ray imaging systems equipped with video monitor suspension manufactured by ge healthcare. systems equipped with lcd or large display monitor suspensions are not affected. it has been identified during several preventive maintenance activities that the 4 outer screws that hold the overhead video monitor suspension to the carriage were found missing since installation of the system. there is a potential that the system has not been installed per specified installation requirements. the manufacturer is not aware of any fall of the overhead monitor suspension. however, missing screws may increase the risk for fall of the monitor suspension. no injury has been reported due to this issue. the manufacturer will inspect all potentially affected systems to verify that the overhead video monitor suspensions are properly installed and will correct all affected systems. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con309649 if you are in possession of the product, please contact your supplier for necessary actions. posted on 10 september 2013.

Device

Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardi...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems
  • Manufacturer
    GE Healthcare

Manufacturer

GE Healthcare