Events

Alerte De Sécurité sur pedal of footswitch for philips multidiagnost eleva fd systems and allura xper 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 Philips 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
    2014-07-11
  • Date de publication de l'événement
    2014-07-11
  • 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_20140711.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: pedal of footswitch for philips multidiagnost eleva fd systems and allura xper systems medical device manufacturer, philips healthcare, has issued a field safety notice concerning its footswitches for multidiagnost eleva fd systems and allura xper systems. according to the manufacturer, if a footswitch is frequently used on an anti-fatigue mat, on a not flat surface or in the pedestal, the footswitch pedals may get bent. this might cause an intermittent or continuous inability of making live fluoro images or exposures. in case the fluoro pedal is bent and live fluoro is not available, the exposure pedal of the footswitch or the handswitch may be used to generate a live image in order to finish a procedure. this will lead to a higher dose but it outweighs a possible safety risk. the manufacturer advises users that before the start of a procedure, the footswitch should be inspected for possible bent pedals. if bent pedals are found, the procedure should not continue. furthermore, the manufacturer would arrange a mechanical hardware update of the footswitch in order to prevent bent pedals. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 11 july 2014.

Device

pedal of footswitch for philips multidiagnost eleva fd systems and allura xper systems
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Pedal of footswitch for Philips MultiDiagnost Eleva FD Systems and Allura Xper Systems
  • Manufacturer
    Philips Healthcare

Manufacturer

Philips Healthcare
  • Société-mère du fabricant (2017)
    Philips
  • Source
    DH