Events

Rappel de GE X-Ray Systems with CRT Video Monitor Suspensions

Selon New Zealand Medicines and Medical Devices Safety Authority, ce/cet/cette rappel concerne un dispositif en/au/aux/à New Zealand qui a été fabriqué par GE Medical Systems LLC.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    15819
  • Date de mise en oeuvre de l'événement
    2013-12-09
  • Pays de l'événement
    New Zealand
  • Source de l'événement
    NZMMDSA
  • URL de la source de l'événement
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alertes
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notes supplémentaires dans les données
    Recalling Organisation: GE Healthcare Limited, 8 Tangihua Street, Auckland 1010
  • Cause
    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 your system has not been installed per specified installation requirements. ge healthcare 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.
  • Action
    Product to be modified

Device

GE X-Ray Systems with CRT Video Monitor Suspensions
  • Modèle / numéro de série
    Model: Precision 500D, Legacy, Prestilix, Monitrol ,RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII, Affected: All CRT Monitor suspension installed since Jan 1993 with products Precision 500D, Legacy, Prestilix, Monitrol ,RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII
  • Manufacturer
    GE Medical Systems LLC

Manufacturer

GE Medical Systems LLC