Events

Alerte De Sécurité sur Magnetic Resonance 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 Medical Systems.

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
    2015-01-08
  • Date de publication de l'événement
    2015-01-08
  • 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_20150108.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 medical systems magnetic resonance imaging systems health canada posted a medical device safety alert concerning various magnetic resonance imaging (mri) systems, manufactured by ge medical systems. the affected devices are identified as follow:- msk extreme - mri system optima mr430s 1.5t - mri system signa hde 1.5t mri system discovery mr750w 3.0t mri system 1.5t signa horizon mri system signa 1.5t excite hd magne - mri system 3.0t signa hdx mri system 1.5t signa hdx mri system discovery mr750 mri system 1.5t signa infinity twinspeed with excite mri syst signa 1.5t infinity excite mri system signa hdxt 1.5t mri system discovery mr450 1.5t mri system signa hdi 1.5 t mri system -16 channel mobile optima mr450w -16ch mri system optima mr450w -32ch mri system optima mr450w -gem mri system optima mr360 main unit in the affected devices, magnet rundown unit (mru) may not be connected to the magnet. if the mru is disconnected, the mru will not function as expected and will not quench the magnet when the button is pressed. in emergency situations, a disconnected mru could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. the mru must be connected to the magnet at all times. for details, please refer to the following health canada websites: http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/43153r-eng.Php http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/43157r-eng.Php http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/43103r-eng.Php http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/43165r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 8 january 2015.

Device

Magnetic Resonance Imaging Systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: GE Medical Systems Magnetic Resonance Imaging Systems
  • Manufacturer
    GE Medical Systems

Manufacturer

GE Medical Systems